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Results for “CD4 Lymphocyte Count”

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PubMed1998

A randomized comparative trial of stavudine (d4T) versus zidovudine (ZDV, AZT) in children with human immunodeficiency virus infection. AIDS Clinical Trials Group 240 Team.

OBJECTIVES: To compare the safety and tolerance of stavudine (d4T) versus zidovudine (ZDV, AZT) in symptomatic human immunodeficiency virus-infected children 3 months to 6 years of age. METHODS: In an initially double-blind trial, 212 evaluable human immunodeficiency virus-infected children who had received no more than 6 weeks of previous antiretroviral therapy were randomized to receive either d4T (1 mg/kg orally every 12 hours, maximum 40 mg orally every 12 hours) or zidovudine (180 mg/m2 orally every 6 hours, maximum 200 mg orally every 6 hours). The study was unblinded after a median follow-up period of 6.3 months; median follow-up at study closure was 17.3 months. Tolerance, safety, disease progression, and immunologic responses were evaluated. RESULTS: The patient population was young (median age, 1.2 years; range, 0.3 to 6.4 years), with a median baseline CD4+ lymphocyte count of 965 cells/microL (range, 18 to 4238 cells/microL). Neutropenia < 400/microL occurred significantly more commonly among zidovudine recipients (1-year event rates of 20% both up to the time of unblinding and throughout the entire study) than among children receiving d4T (1-year event rates of 5% up to the time of unblinding and 6% throughout the entire study). In exploratory activity analyses using all data collected until study closure, children treated with d4T showed consistently greater positive changes from baseline in weight-for-age-and-gender z scores. As expected in this population of young children, median absolute CD4+ lymphocyte counts decreased in both treatment groups. Smaller changes from baseline were noted among d4T recipients. CONCLUSIONS: In children between the ages of 3 months and 6 years, d4T and zidovudine are largely comparable in terms of safety and tolerance. Neutropenia occurs significantly less commonly among children treated with d4T. There was evidence that weight gain and absolute CD4+ lymphocyte counts were better maintained in children receiving d4T.

Anti-HIV Agents↗

PubMed1995

Incidence and prognostic value of malnutrition and wasting in human immunodeficiency virus-infected outpatients.

Although malnutrition and wasting are known features of human immunodeficiency virus (HIV) infection, their incidence and possible association with immunologic impairment are largely unknown, as is the prognostic value of the nutritional state. Nutritional, clinical, and immunologic parameters were measured in 100 outpatients in different stages of HIV infection. In addition, 39 patients with AIDS were prospectively followed for a mean period of 343 (range, 53-650) days. Sixty-three percent of the patients showed evidence of malnutrition, 21% suffered from wasting. A reduced body cell mass and decreased serum albumin levels were observed in 32 and 14%, respectively, predominantly in more advanced disease stages. Fourteen of 39 AIDS patients died after a mean survival of 212 days. Survivors showed significantly larger initial body cell mass values and higher initial serum albumin levels compared with nonsurvivors, whereas CD4+ lymphocyte counts, disease complications, and medication were all similar in both groups. Kaplan-Meier analyses revealed a significantly prolonged survival in patients with a body cell mass > 30% of body weight or serum albumin levels exceeding 30 g/L. Factor analyses indicated that the parameters of nutritional state were independent from each other and from CD4+ lymphocyte counts. Malnutrition occurs frequently during HIV infection and increases with disease progress. It strongly predicts patient survival independent of CD4+ lymphocyte counts.

Acquired Immunodeficiency Syndrome↗

PubMed1995

A phase I/II evaluation of stavudine (d4T) in children with human immunodeficiency virus infection.

OBJECTIVES: To determine the pharmacokinetic properties, tolerance, safety, and preliminary activity of stavudine in human immunodeficiency virus (HIV)-infected children. DESIGN: Phase I/II, open and dose-ranging (0.125 to 4 mg/kg/day in two divided doses). PATIENTS: Thirty-seven HIV-infected children (median age, 5.5 years; range, 7 months to 15 years) with a median CD4+ lymphocyte count at baseline of 242 cells/microL (range 2 to 2290 cells/microL). Thirty children had symptomatic HIV disease at entry; seven had HIV-related immunosuppression alone. Twenty-nine subjects had a history of prior zidovudine (ZDV) therapy. RESULTS: As compared with adults receiving the same weight-adjusted doses, the children we studied had lower maximum observed stavudine plasma concentrations (CMAX) and area under the plasma concentration versus time curves (AUC), and more rapid stavudine elimination. The absolute oral bioavailability of the drug ranged from 61% to 78%. There was no plasma accumulation of the drug between day 1 and week 12. Week 12 cerebrospinal fluid stavudine concentrations in seven subjects, obtained approximately 2 to 3 hours after oral doses, ranged from 16% to 97% of concomitant plasma concentrations. Stavudine was well-tolerated and there were no dose-related clinical or laboratory adverse events. One subject with baseline neurologic abnormalities experienced a transient episode of apparent pain or discomfort in her fingers, possibly related to stavudine. All other adverse events were attributed to underlying disease. Stavudine activity, measured indirectly by CD4+ lymphocyte count and serum p24 antigen concentration changes, was observed in some subjects. Progression of HIV disease and survival correlated with prior ZDV therapy, HIV disease classification, baseline CD4+ lymphocyte count, and weight growth velocity. CONCLUSIONS: Stavudine appears to hold promise for the treatment of HIV infection in children. Its pharmacokinetic properties are consistent and predictable, and it appears to be remarkably well-tolerated and safe. Although our study was not designed to assess the drug's efficacy, preliminary clinical and laboratory evidence of activity was observed.

Administration, Oral↗

PubMed1998

Plasma cytomegalovirus (CMV) DNA load predicts CMV disease and survival in AIDS patients.

In this study, baseline plasma from 619 persons with acquired immunodeficiency syndrome (AIDS) (median CD4+ lymphocyte count -21/microl) who participated in a trial to determine the efficacy of oral ganciclovir for cytomegalovirus (CMV) disease prevention were evaluated for CMV DNA load by qualitative and quantitative polymerase chain reaction (PCR), and correlated with the development of CMV disease and survival. For participants without detectable plasma CMV DNA, the 12-mo Kaplan-Meier CMV disease event rate was 14% and 1% for the placebo and ganciclovir groups, respectively (P < 0.001). For PCR positive participants, CMV disease developed in 43% of placebo and 26% ganciclovir recipients (P < 0.017). Among placebo recipients, CMV PCR positivity was associated with a 3.4-fold increased risk of developing CMV disease (P < 0.001) whereas CD4+ lymphocyte count was not a useful predictor (P = 0.47). A positive plasma CMV DNA PCR was also associated with a 2.5-fold increased risk of death. Each log10 increase in baseline CMV DNA load was associated with a 3.1-fold increase in CMV disease (P < 0.001) and a 2.2-fold increase in mortality (P < 0.001). These data indicate that the risk of developing CMV disease and death in persons with advanced AIDS is directly related to the quantity of CMV DNA in plasma, and is a better predictor than CD4+ lymphocyte count in this population.

AIDS-Related Opportunistic Infections↗

PubMed1994

Cytotoxic T-lymphocytes that kill autologous CD4+ lymphocytes are associated with CD4+ lymphocyte depletion in HIV-1 infection.

Human immunodeficiency virus type 1 (HIV-1)-infected individuals, but not HIV-seronegative controls, have non-HLA-restricted T-cell receptor alpha beta+ CD8+ cytotoxic T-lymphocytes (CTL) that kill activated uninfected CD4+ lymphocytes. In vitro stimulation of peripheral blood mononuclear cells from HIV-1-infected individuals with concanavalin A (Con A) or by coculture with phytohemagglutinin-activated autologous lymphoblasts induced CTL that killed autologous and heterologous CD4+ lymphocytes, but not Con A-activated CD8+ lymphocytes or Epstein-Barr virus (EBV)-transformed B lymphocytes. EBV did not stimulate such CTL in two subjects tested, although stimulation with Con A or autologous lymphoblasts induced CTL activity against CD4+ lymphocytes in both subjects. CTL activity against autologous CD4+ lymphocytes varied over time; killing of heterologous CD4+ lymphocytes was often higher than that of autologous CD4+ lymphocytes. HIV-infected individuals with Con A-inducible CTL against autologous CD4+ lymphocytes lost more CD4+ lymphocytes within 6 months of testing than HIV-infected individuals with no such CTL (p < .01). The mean (+/- SD) decrease in CD4+ lymphocyte counts in a group of HIV-infected individuals with CTL activity against autologous CD4+ lymphocytes was 121 +/- 84, or 36%, of total CD4+ lymphocytes over 6 months. In contrast, there was no significant change in mean CD4+ lymphocyte count over 6 months in a group of HIV-infected individuals without CTL activity against autologous CD4+ lymphocytes. In some HIV-infected individuals, CTL activity against autologous CD4+ lymphocytes fell coincident with a drop in CD4+ lymphocyte number in vivo.(ABSTRACT TRUNCATED AT 250 WORDS)

CD4-Positive T-Lymphocytes↗

PubMed1993

Zalcitabine.

OBJECTIVE: To review the chemistry, intracellular metabolism, pharmacokinetics, and clinical trials of zalcitabine (2'3'-dideoxycytidine, ddC). DATA SOURCES: English-language articles and conference procedings. The indexing terms used were zalcitabine, 2'3'-dideoxycytidine, and ddC. STUDY SELECTION: In addition to the manufacturer's package insert, available Phase I and Phase I/II studies were reviewed. DATA EXTRACTION: Clinical experience with ddC has been limited to uncontrolled studies and an expanded-access program. Efficacy was evaluated solely on surrogate markers of HIV disease: CD4+ lymphocyte counts and p24 antigen determinations. Clinical endpoints, such as disease progression and survival rates, must be provided to the Food and Drug Administration (FDA) for continued approval. DATA SYNTHESIS: The FDA has approved use of ddC in combination with zidovudine (ZDV) as therapy of HIV infection for patients with CD4+ lymphocyte counts < or = 300 cells/mm3 who have experienced significant clinical or immunologic deterioration. Although ddC has the same mechanism of action as other nucleoside analogs, it is more potent on a molar basis. The drug is stable in gastric pH and has good bioavailability (approximately 70-90 percent), but is rapidly cleared from plasma (half life approximately 1-3 h). Intracellular concentrations of ddC triphosphate, the active form, are probably related to plasma concentrations, yet may persist in cells longer than the parent drug persists in plasma. When used as primary therapy in patients with CD4+ < or = 300 cells/mm3, ddC/ZDV increased CD4+ lymphocyte counts and reduced plasma p24 antigen concentrations. In comparison to ZDV monotherapy data taken from other studies, ddC/ZDV appeared to demonstrate a more pronounced and sustained increase in CD4+ cell counts; however, this observation cannot be confirmed until the results of ZDV-controlled comparisons are available. Overall, 17-31 percent of the patients receiving the currently recommended initial dosage of ddC experience peripheral neuropathy. CONCLUSIONS: In combination with ZDV, ddC appears to augment the CD4+ cell response of ZDV monotherapy in the treatment of HIV infection for ZDV-naive patients, although controlled studies and rigorous statistical analyses are lacking at present. The efficacy of ddC/ZDV in patients who received prior treatment with ZDV monotherapy is unclear at the present.

Adolescent↗

PubMed2005

Evaluation of stroma in human immunodeficiency virus/acquired immunodeficiency syndrome-affected bone marrows and correlation with CD4 counts.

CONTEXT: Little is known about cellular and extracellular composition of fibrosis in bone marrows in the context of human immunodeficiency virus/acquired immunodeficiency syndrome. OBJECTIVE: To evaluate the stromal composition of bone marrows affected by human immunodeficiency virus/ acquired immunodeficiency syndrome and to correlate this with laboratory parameters including CD4 lymphocyte counts. DESIGN: We evaluated extracellular matrix and stromal cell composition in bone marrows and correlated these results with hematologic parameters. Extracellular matrix, stromal cells, and smooth muscle differentiation were evaluated by immunohistochemistry for collagen type IV expression and reticulin staining, an antibody directed against low-affinity nerve growth factor receptor (a marker of adventitial reticular cells), and actin staining, respectively. Concurrent laboratory information was collected, including white blood cell count, hemoglobin, platelet count, CD4 count, CD8 count, CD4/CD8 ratio, and absolute lymphocyte count. PATIENTS: Bone marrows of 35 patients with human immunodeficiency virus/acquired immunodeficiency syndrome were evaluated. MAIN OUTCOME MEASURES: Correlation of reticulin, low-affinity nerve growth factor receptor, actin, and collagen IV staining with hematologic parameters. RESULTS: More than half of the bone marrows showed moderate to severe reticulin fibrosis. The degree of reticulin fibrosis was correlated with the degree of low-affinity nerve growth factor receptor expression (P = .048). Actin expression was identified in only 3 of 35 cases and collagen IV in only 5 of 35 cases. No statistical relationship between degree of fibrosis and CD4 count was identified. Lower levels of low-affinity nerve growth factor receptor expression were associated with CD4 counts of >100 (P = .04). Marrow fibrosis was present in almost all cases studied (97%), and the staining of adventitial reticular cells correlated with the degree of reticulin fibrosis. CONCLUSIONS: There does not appear to be a correlation between CD4 count and degree of fibrosis, suggesting that the mechanism of fibrosis is independent of disease status.

Acquired Immunodeficiency Syndrome↗

PubMed1995

A manual bead assay for the determination of absolute CD4+ and CD8+ lymphocyte counts in human immunodeficiency virus-infected individuals.

CD4+ T lymphocytes are currently the most common surrogate marker indicating disease progression in individuals infected with human immunodeficiency virus (HIV). Since the cost of enumerating lymphocyte phenotypes is quite high, an inexpensive bead assay analyzed by light microscopy (cytosphere assay; Coulter Corporation, Hialeah, Fla.) was developed as an alternative method for counting CD4+ and CD8+ T lymphocytes. To evaluate the reliability of the cytosphere assay, heparinized blood was collected from 117 HIV-infected individuals and tested for both CD4+ and CD8+ lymphocytes by flow cytometry and the cytosphere assay. The Pearson correlation coefficient of the cytosphere assay compared with that of flow cytometry for CD4+ T lymphocytes was 0.93, with mean values +/- standard deviations of 534 +/- 509 by flow cytometry and 499 +/- 477 by the cytosphere assay. The correlation coefficient for CD8+ T lymphocytes was 0.86, with mean values of 831 +/- 543 by flow cytometry and 746 +/- 472 by the cytosphere assay. The sensitivity and specificity of the cytosphere assay in determining absolute CD4+ T-lymphocyte counts of less than 200/microliters were 97.6 and 94.7%, respectively. The positive predictive value was 90.9%, and the negative predictive value was 98.6%. The cytosphere assay was highly correlative to flow cytometry in determining CD4+ and CD8+ T-lymphocyte counts among HIV-infected patients. The ease and limited resources needed to perform this test make it ideal in developing countries and other areas where technology and finances are limited.

CD4 Lymphocyte Count↗

PubMed1994

[Total lymphocyte-count as a substitute for CD4 positive lymphocyte determination].

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Acquired Immunodeficiency Syndrome↗

PubMed1993

Low-dose oral recombinant interferon-alpha A in patients with HIV-1 infection: a blinded pilot study.

OBJECTIVE: To evaluate the efficacy of low-dose oral recombinant interferon-alpha (IFN-alpha A) on clinical parameters, body weight, CD4+ lymphocyte counts and natural killer cell cytolytic activity in HIV-infected patients. DESIGN: Blinded crossover trial with controls for the protein and diluent components of the drug preparation. SETTING: Medical school outpatient referral center. PATIENTS, PARTICIPANTS: Eight patients with HIV-1 infection and a CD4+ lymphocyte count between 150 and 600 x 10(6)/l. Concurrent use of zidovudine was permitted. INTERVENTIONS: Patients received (daily, by mouth) 10 ml of a study solution of 2.5% albumin for 6 weeks, 150 IU IFN-alpha A for 6 weeks, and normal saline for 6 weeks. MAIN OUTCOME MEASURES: After two baseline visits, clinical assessments, vital signs, body weight, and laboratory tests, including enumeration of number and percentage of CD4+ and CD8+ lymphocytes and natural killer cell cytolytic activity, were performed every 3 weeks. Complete physical examinations were conducted every 6 weeks. RESULTS: No significant clinical or laboratory changes were observed during treatment with IFN-alpha A. Peak CD4+ lymphocyte counts were achieved at baseline in one patient, during albumin treatment in two patients, during IFN-alpha A treatment in one patient, and during saline treatment in four patients. All patients remained HIV-seropositive. Treatments were well-tolerated. CONCLUSION: This blinded pilot study of orally administered IFN-alpha A (150 IU daily for 6 weeks) did not demonstrate clinical benefit in HIV-infected patients.

Administration, Oral↗

PubMed2000

Are there gender differences in starting protease inhibitors, HAART, and disease progression despite equal access to care?

OBJECTIVES: To describe gender differences in starting and response to treatment regimens and long-term clinical outcome in a well-characterized regional population from the Southern Alberta HIV Clinic (SAC) of 1403 patients, where all medical care for HIV, including physician fees, laboratory tests, and antiretroviral drug costs is provided free of charge. DESIGN: Observational cohort study. METHODS: Cox proportional hazards models were used to examine the relative risk of starting treatment regimens and disease progression (new AIDS-defining illness or death). RESULTS: There are 126 women in the SAC (9.0%). The median CD4 lymphocyte count at first visit among all patients was 350 cells/mm3, and was significantly higher among women than men (428 cells/mm3 versus 345 cells/mm3, respectively; p = 0.0024). Participating women were less well educated than participating men; 29% of women did not proceed beyond a tenth grade education compared with 13% of men; only 28% of women went to college or received a degree in contrast to 40% of men (p <. 001). The proportion of women in the cohort has increased over the past 5 years (p <.001). During a median follow-up period of 35 months that dates back as far as 1985, 572 patients (40.8%) died or progressed to a new AIDS-defining illness, of whom 30 were women (5. 2%). In a multivariate Cox model stratified by calendar quartile of first visit and adjusted for latest CD4, AIDS status, age, exposure group, education, and prior treatment, women were significantly less likely to start highly active antiretroviral therapy (HAART; defined as at least three antiretrovirals taken consecutively; relative hazard [RH], 0.69; 95% confidence interval [CI], 0.49-0.98; p =.033), significantly less likely to start a protease inhibitor containing treatment regimen (RH, 0.71; 95% CI, 0.52-0.98; p =.040) and significantly less likely to start a HAART regimen including a protease inhibitor (RH, 0.69; 95% CI, 0.48-1.00; p =.049). After adjustment for potentially confounding variables such as CD4 lymphocyte count and treatment regimen, no difference in disease progression was found between men and women (RH, 0.77; 95% CI, 0. 49-1.19; p =.24). Among patients who started HAART, the CD4 lymphocyte count and viral load at starting treatment regimens was similar between men and women, as were the immunologic and virologic response following initiation of treatment. CONCLUSIONS: Despite free access to antiretrovirals, women in the SAC were significantly less likely to start HAART treatment regimens, and the reasons for this need further investigation. Response to treatment was similar between genders. No evidence was found for a poorer long-term clinical outcome in women, but given the proven large clinical benefits of HAART, this may change in the future.

Adult↗

PubMed1995

Recovery of human immunodeficiency virus from peritoneal dialysis effluent.

Increasing numbers of HIV-infected patients who have ESRD are being treated with continuous ambulatory peritoneal dialysis (CAPD). To investigate the potential infectious nature of peritoneal dialysate (PD), the peritoneal dialysis effluent was studied in 14 patients on CAPD who were known to be HIV antibody positive. Peripheral blood mononuclear cells and the sediment of PD were obtained from each patient and subjected to a qualitative microculture assay using a coculture of patient cells or PD fluid with peripheral blood mononuclear cells from non-HIV-infected individuals. Samples from the coculture were collected twice weekly for HIV P24 antigen determination as a marker of viral replication. PD, white blood cell and red blood cell counts, and peripheral blood CD4 lymphocyte counts were also measured. All 14 patients developed a positive blood culture by Day 3. Twelve of the 14 patients developed a positive PD fluid culture. The mean CD4 count was 310 cells/mm3. No patient had clinical or cellular evidence of peritonitis at the time of fluid sampling. These data indicate that peritoneal dialysis effluent from patients who are HIV antibody positive is potentially infectious.

Adult↗

PubMed1999

Anaemia is an independent predictive marker for clinical prognosis in HIV-infected patients from across Europe. EuroSIDA study group.

OBJECTIVES: To describe changes in haemoglobin over time and to determine the joint prognostic value of the current haemoglobin, CD4 lymphocyte count and viral load among patients from across Europe. PATIENTS: The analysis included 6725 patients from EuroSIDA, an observational, prospective cohort of patients with HIV from across Europe. METHODS: Normal haemoglobin was defined as haemoglobin greater than 14 g/dl for men and 12 g/dl for women; mild anaemia was 8-14 g/dl for men and 8-12 g/dl for women; severe anaemia was defined as less than 8 g/dl for both males and females. Linear regression techniques were used to estimate the annual change in haemoglobin; standard survival techniques were used to describe disease progression and risk of death. RESULTS: At recruitment to the study, 40.4% had normal levels of haemoglobin, 58.2% had mild anaemia and 1.4% had severe anaemia. At 12 months after recruitment, the proportion of patients estimated to have died was 3.1% [95% confidence interval (CI) 2.3-3.9] for patients without anaemia, 15.9% for patients with mild anaemia (95% CI 14.5-17.2) and 40.8% for patients with severe anaemia (95% CI 27.9-53.6; P < 0.0001). In a multivariate, time-updated Cox proportional hazards model, adjusted for demographic factors, AIDS status and each antiretroviral treatment as time-dependent covariates, a 1 g/dl decrease in the latest haemoglobin level increased the hazard of death by 57% [relative hazard (RH) 1.57; 95% CI 1.41-1.75; P < 0.0001], a 50% drop in the most recent CD4 lymphocyte count increased the hazard by 51% (RH 1.51; 95% CI 1.35-1.70; P < 0.0001) and a log increase in the latest viral load increased the hazard by 37% (RH 1.37; 95% CI 1.15-1.63; P = 0.0005). CONCLUSIONS: Severe anaemia occurred infrequently among these patients but was associated with a much faster rate of disease progression. Among patients with similar CD4 lymphocyte counts and viral load, the latest value of haemoglobin was a strong independent prognostic marker for death.

Adolescent↗

PubMed1997

Comparative rates of disease progression among persons infected with the same or different HIV-1 strains. The Transfusion Safety Study Group.

Rates of HIV-1 progression vary widely. To investigate the relative effects of viral and host characteristics on course, we compared persons infected by the same and different subtype B strains. Forty-three infection chain clusters were identified, each defined by an infected blood donor, that donor's recipients, and the recipients' sexual partners, representing second and third generations of infection. Analysis of levels and rates of change in CD4 lymphocyte counts and viral load showed that members within a cluster were no more alike in their rates of change in CD4+ lymphocyte counts or viral RNA levels than among clusters. Differences in entry viral RNA levels by cluster were marginal and markedly smaller than interindividual differences. These results argue that, in general, host factors outweigh differences in viral strain in determining HIV-1 disease progression.

Blood Donors↗

PubMed2002

Social network, social support and the rate of decline of CD4 lymphocytes in asymptomatic HIV-positive homosexual men.

AIMS: To test a stress-disease hypothesis by investigating the influence of social network and social support factors on the course over time of the CD4 lymphocytes in an HIV-positive population of gay men. METHODS: The study is a prospective cohort study of a representative population of HIV-positive gay men, undertaken at the Department of Infectious Diseases, Malmö University Hospital. This is the only clinic providing care for HIV-positive individuals in the city of Malmö in southern Sweden (population 248,000). A total of 115 HIV-positive homosexual men, who had not received an AIDS diagnosis, were invited to take part in the study. Seventy-five men (65%) accepted to be interviewed and 64 men (56%) fulfilled the inclusion criteria for the statistical analysis. RESULTS: In a multivariate analysis adjustments were made for age, level of the first CD4 count and time since first contact with the clinic. Men with high family contact frequency had a longer half-life (20.3 years) of the CD4 lymphocyte count than men with a low family contact frequency (7.4 years) (p = 0.03). Men with high social participation also had a longer half-life of CD4 lymphocyte count (14.7 years), compared with men with low social participation (6.3 years, p = 0.10). CONCLUSIONS: The findings of this study imply the importance of social support and social network factors as modifiers of the rate of decline of the CD4 lymphocyte level, which is an important prognostic marker of survival in HIV-positive homosexual men.

Adult↗

PubMedDate not supplied

Longitudinal analysis of the 90K glycoprotein in the Italian HIV-seroconversion study: temporal trend and predictability of the maturity of HIV infection.

OBJECTIVES: To evaluate the level of 90K as a predictor of AIDS; to describe 90K levels over time after HIV serconversion; and to evaluate the 90K level as a marker of the maturity of infection. DESIGN: Prospective incident cohort of HIV-infected individuals with documented dates of seroconversion. METHODS: Cox models were applied to estimate the crude and adjusted relative hazards (RH) of AIDS by level of 90K. Regression models were applied to describe the temporal trend and the correlates of the level of 90K over time after HIV-seroconversion. Logistic models were applied to evaluate the probability of a sample of 90K having been taken within a certain time period after HIV-seroconversion. RESULTS: The study population consisted of 150 participants of the Italian Seroconversion Study. A total of 429 measurements of 90K were taken. Both early and later measurements of 90K were highly predictive of AIDS, also when adjusting for CD4 lymphocyte count and HIV load. The 90K level (U/ml) increased by 10% annually (95% CI: 7%-13%); the increase over time was linear. IDUs had higher 90K levels than heterosexuals and homosexuals over the course of HIV disease. High 90K levels were highly predictive of distant seroconversions (age-adjusted probability, 74%), whereas were poorly predictive of recent seroconversions (age-adjusted probability, 5%); the results were similar for the predictability of CD4 lymphocyte count. CONCLUSIONS: The level of 90K is a useful prognostic tool for clinical purposes. As a marker of the maturity of infection, 90K is similar to the CD4 lymphocyte count, with the advantage of being able to use serum instead of fresh whole blood. It has a good capacity to identify distant infections.

Acquired Immunodeficiency Syndrome↗

PubMed1997

Progression to acquired immunodeficiency syndrome is influenced by CD4 T-lymphocyte count and time since seroconversion.

Progression to acquired immunodeficiency syndrome (AIDS) among persons infected with human immunodeficiency virus (HIV) varies considerably and may be influenced by factors such as age, smoking, number of male partners per year, and CD4 T-lymphocyte count. The loss of CD4 lymphocytes is known to be the dominant factor in the progression to AIDS. However, it is unclear whether the effect of the CD4 lymphocyte count is of such importance that persons with similar CD4 cell counts who have been infected for widely different lengths of time have the same risk of AIDS. While a CD4 count is easily obtainable, the precise amount of time since HIV infection is in most circumstances difficult to assess. In the present analysis, 259 Danish and 245 American homosexual men were followed for up to 14 years from 1981 to 1995. Two hundred and one persons seroconverted during the study period, and 112 had developed AIDS before the end of follow-up. CD4 lymphocyte count was highly correlated with the risk of developing AIDS (p < 0.001), but AIDS risk was not affected significantly by either age at infection, smoking, or number of male partners per year (p > 0.20 in all cases). Controlled for CD4 lymphocyte count, time since seroconversion was significant in explaining the risk of AIDS (p = 0.018), with a lower risk being seen during the first 3 years after seroconversion but no effect thereafter. These data confirm the central importance of CD4 lymphocyte level in the progression of HIV disease to AIDS, and suggest that rapid progression within 3 years of infection may be related to factors other than CD4 cell count.

Acquired Immunodeficiency Syndrome↗

PubMed2000

[The prognostic markers of survival and progression in HIV-1 infection. A study of CD4+ lymphocytes, antigen p24 and viral load during 3 years in a cohort of 251 patients].

BACKGROUND: Prospective study of survival and AIDS or death progression in a cohort of 251 HIV infected patients whose seroconversion time is unknown, with 1 main objective: To analyse CD4+ lymphocytes count, p24 antigen plasmatic levels and viral load as surrogate markers. PATIENTS AND METHODS: 251 patients were included, most of them undergoing antiretroviral therapy, followed consecutively in the HIV/AIDS Unity of Internal Medicine Service of the Hospital Universitario Arnau de Vilanova in Lleida. We made clinical and analytical baseline studies and every 3 months thereafter. In relation to CD4+ lymphocytes, 3 groups were established: group I, 500 or more cells/mL; group II, 200-499 cells/mL and group III, < 200 cells/mL. In the same way, with p24 antigen we established 3 group: group I, < 20 pg/mL, group II, 20-39 pg/mL, group III 40 or more pg/mL. We studied survival in relation to baseline levels and stability, the latter being understood as persistent levels in the initial group, or better, over 3 year period. Survival analysis was made by Kaplan-Meier estimation. Relative risk was calculated by Cox's proportional hazards model. RESULTS: During the 36 months of follow-up 53 patients died. AIDS progression risk or death was 4.8 times higher for the p24 antigen > = 40 pg/mL group than for the p24 antigen < 20 pg/mL one; patients with p24 antigen between 20-39 pg/mL relative risk was 2.5 times higher than those included in p24 antigen < 20 pg/mL group. These results emphasize that if we take into account the p24 antigen stability during these 36 months. In relation to progression study, 36 patients progressed. AIDS progression risk or death for p24 antigen > = 40 pg/mL group was 7.69 times higher in relation to that with p24 antigen levels between 20-39 pg/mL. The bivariable study shows that CD4 lymphocytes counts and p24 antigen level have quite an independent value. The comparison with viral load by PCR determination makes manifest discrepancy, difficult to explain. CONCLUSIONS: p24 antigen plasma level is a good survival and AIDS progress or death surrogate markers in HIV infected patients, and it is useful for 3 years or more. An isolated value < 20 pg/mL and, furthermore, the stability in successive controls under this concentration is a sign of good prognosis. Its value is emphasized with CD4+ lymphocytes count. It seem necessary that more comparative studies with viral load are required.

Adult↗