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Results for “CD4 Lymphocyte Count”

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PubMed2003

Plasma vitamin A and zinc levels in HIV-infected adults in Cape Town, South Africa.

A cross-sectional study of 132 adults attending an HIV clinic in Cape Town, South Africa, was conducted to determine predictors of low plasma vitamin A and Zn levels. No patients were on antiretroviral therapy. The possible confounding effect of the acute-phase response was controlled by including C-reactive protein levels in multivariate analysis and by excluding active opportunistic infections. Retinol levels were low (<1.05 micromol/l) in 39 % of patients with early disease (WHO clinical stages I and II) compared with 48 and 79 % of patients with WHO stage III and IV respectively (P<0.01). Plasma Zn levels were low (<10.7 micromol/l) in 20 % of patients with early disease v. 36 and 45 % with stage III and IV disease respectively (P<0.05). C-reactive protein levels were normal in 63 % of subjects. Weak, positive associations were found between CD4+ lymphocyte count and plasma levels of retinol (r 0.27; 95 % CI 0.1, 0.43) and Zn (r 0.31; 95 % CI 0.25, 0.46). Multivariate analysis showed the following independent predictors of low retinol levels: WHO stage IV (odds ratio 3.4; 95 % CI 2.1, 5.7) and body weight (odds ratio per 5 kg decrease 1.15; 95 % CI, 1.08, 1.25), while only body weight was significantly associated with low Zn levels (OR per 5 kg decrease 1.19; 95 % CI 1.09, 1.30). CD4+ lymphocyte count <200/microl was not significantly associated with either low retinol or Zn levels. In resource-poor settings, simple clinical features (advanced disease and/or weight loss) are associated with lowered blood concentrations of vitamin A and/or Zn. The clinical significance of low plasma retinol and/or Zn levels is unclear and more research is required to establish the role of multiple micronutrient intervention strategies in HIV disease.

Adult↗

PubMed1995

A short-term study of the safety, pharmacokinetics, and efficacy of ritonavir, an inhibitor of HIV-1 protease. European-Australian Collaborative Ritonavir Study Group.

BACKGROUND: Reverse-transcriptase inhibitors have only moderate clinical efficacy against the human immunodeficiency virus type 1 (HIV-1). Ritonavir is an inhibitor of HIV-1 protease with potent in vitro anti-HIV properties and good oral bioavailability. METHODS: We evaluated the antiviral activity and safety of ritonavir in a double-blind, randomized, placebo-controlled phase 1 and 2 study of 84 HIV-positive patients with 50 or more CD4+ lymphocytes per cubic millimeter. The patients were randomly assigned to one of four regimens of ritonavir therapy, or to placebo for four weeks and then (by random assignment) to one of the ritonavir regimens. RESULTS: During the first 4 weeks, increases in CD4+ lymphocyte counts and reductions in the log number of copies of HIV-1 RNA per milliliter of plasma were similar among the four dosage groups, but in the three lower-dosage groups there was a return to base-line levels by 16 weeks. After 32 weeks, in the seven patients in the highest-dosage group (600 mg of ritonavir every 12 hours), the median increase from base line in the CD4+ lymphocyte count was 230 cells per cubic millimeter, and the mean decrease in the plasma concentration of HIV-1 RNA (as measured by a branched-DNA assay) was 0.81 log (95 percent confidence interval, 0.40 to 1.22). In a subgroup of 17 patients in the two higher-dosage groups, RNA was also measured with an assay based on the polymerase chain reaction, and after eight weeks of treatment there was a mean maximal decrease in viral RNA of 1.94 log (95 percent confidence interval, 1.37 to 2.51). Adverse events included nausea, circumoral paresthesia, elevated hepatic aminotransferase levels, and elevated triglyceride levels. Ten withdrawals from the study were judged to be related to ritonavir treatment. CONCLUSIONS: In this short-term study, ritonavir was well tolerated and had potent activity against HIV-1, but its clinical benefits remain to be established.

Adult↗

PubMed1999

A phase I study of abacavir (1592U89) alone and in combination with other antiretroviral agents in infants and children with human immunodeficiency virus infection. AIDS Clinical Trials Group 330 Team.

OBJECTIVES: To evaluate the pharmacokinetic features, safety, and tolerance of abacavir, given alone and in combination with other nucleoside antiretroviral agents, in symptomatic human immunodeficiency virus (HIV)-infected children. METHODS: HIV-infected children discontinued prior antiretroviral therapy and were given abacavir orally, 4 mg/kg every 12 hours for 6 weeks, followed by 8 mg/kg every 12 hours for 6 weeks (n = 39); or 8 mg/kg every 12 hours for 12 weeks (n = 8). Children then were randomized to receive a second nucleoside antiretroviral agent (zidovudine, stavudine, didanosine, or lamivudine), plus abacavir. Pharmacokinetics, safety, tolerance, CD4(+) lymphocyte counts, and plasma HIV RNA concentrations were evaluated. RESULTS: At a dose of 8 mg/kg every 12 hours, area under the plasma concentration-versus-time curves and plasma half-life values were comparable with those reported for adults receiving abacavir at a dose of 300 mg twice daily. One case each of hypersensitivity reaction and peripheral neuropathy occurred during abacavir monotherapy. Three children experienced neutropenia while receiving abacavir in combination with another antiretroviral agent. Mean CD4(+) lymphocyte count and plasma HIV RNA concentration did not change when prior antiretroviral therapy was changed to abacavir monotherapy. CONCLUSIONS: Abacavir therapy is associated with good short-term tolerance and safety in HIV-infected children. Phase III studies are in progress to assess the antiviral activity of abacavir in children and adults.

Adolescent↗

PubMed1999

Stability of cutaneous anergy in women with or at risk for HIV infection. HIV Epidemiology Research Study Group.

OBJECTIVE: To study the stability of cutaneous anergy in women with or at risk for HIV infection. DESIGN: Prospective multicenter cohort study METHODS: Interviews, CD4+ lymphocyte counts, and intradermal skin testing with mumps, Candida, and tetanus toxoid antigens were performed on two occasions at a median interval of 74 weeks in 436 HIV-seropositive and 252 seronegative at-risk women; only 10 (2%) HIV-seropositive women were taking highly active antiretroviral therapy at the time of delayed-type hypersensitivity (DTH) testing. Anergy was defined as induration <2 mm to all three antigens. RESULTS: Skin test reactivity at repeat testing was seen in 202 of 233 (87%) HIV-seronegative women who were not anergic at baseline, compared with 10 (53%) of 19 seronegative women who were anergic at baseline (relative risk [RR], 1.7; 95% confidence interval [CI], 1.07-2.5). Anergy at retesting was seen in 108 of 169 (64%) HIV-seropositive women who were previously anergic, compared with 77 of 267 (29%) who were not previously anergic (RR, 2.2; 95% CI, 1.8-2.8). Among initially anergic seropositive women, CD4+ lymphocyte counts were lower at both initial and follow-up testing in those who remained anergic than in those who reacted at follow-up (p < .001). The relative risks for anergy at retesting of initially anergic seropositive women, compared with initially reactive seropositive women, were related to CD4+ level; 2.5 (95% CI, 1.4-4.3) for CD4+ counts < 200 cells/mm3, 2.0 (95% CI, 1.5-1.7) for CD4+ counts 200-500 cells/mm3, and 1.6 (95% CI, 0.9-2.8) for CD4+ counts >500 cells/mm3. CONCLUSIONS: Although anergic HIV-seropositive women may become reactive, cutaneous anergy predicts a higher likelihood of anergy at retesting as well as lower CD4+ counts. Stability of anergy is greatest in HIV-seropositive women with low CD4+ counts.

CD4 Lymphocyte Count↗

PubMed2000

A comparison of two dosing regimens of zidovudine in Thai adults with early symptomatic HIV infection. Conducting clinical HIV trials in South-East Asia.

AIM: To compare the clinical and immunological efficacy, and tolerance of two dosage regimens of zidovudine (ZDV) in an adult Thai population with early symptomatic human immunodeficiency virus (HIV) disease and to identify important clinical issues associated with conducting HIV trials in South-East Asia. METHODS: HIV-infected Thai adults, with early symptomatic HIV disease and CD4 lymphocyte counts less than 400/mm3, who were managed in the infectious diseases clinics at two university teaching hospitals in Bangkok, Thailand, were enrolled in a randomised, open-label, dose-regimen comparison trial of ZDV. Two oral ZDV dosing regimens: regimen A, 100 mg tid+200 mg nocte (ZDV-A) vs regimen B, 250 mg bid (ZDV-B) were compared. The main outcome measures were: 1. Clinical efficacy: rate of progression to acquired immunodeficiency syndrome (AIDS) or death. 2. Immunologic efficacy: changes in CD4 lymphocyte numbers compared to baseline; rate of decline of CD4 lymphocyte numbers to less than 100/mm3. 3. Toxicity, as defined by clinical symptomatology and laboratory parameters. RESULTS: Two hundred and four patients were enrolled (103 ZDV-A; 101 ZDV-B) of whom 195 were followed beyond baseline. Patients were typical of those encountered with HIV in Thailand: mean age 33 years; 89% male; 88% heterosexual HIV acquisition; mean baseline CD4 lymphocyte count 241/mm3. Follow-up while on therapy was comparable for the two groups (mean+/-SD): 533+/-236 days (ZDV-A) vs 592+/-210 days (ZDV-B). One hundred and eleven patients (57%; 51 ZDV-A; 60 ZDV-B) were treated for at least 22 months (669+/-30 days). Clinical and immunological outcomes for ZDV-A and ZDV-B, including rate of progression to AIDS or death, development of non-AIDS-defining opportunistic infections, mean changes in CD4 lymphocyte numbers/mm3, difference in area under the CD4:time distribution curve and difference in the rate of decline of CD4 lymphocyte numbers to less than 100/mm3, were not significantly different. The presence of oral hairy leukoplakia or unintentional weight loss of 10-20% at enrollment were significantly associated with the later development of AIDS (p=0.03 and 0.04, respectively). ZDV-associated toxicity was similar for both regimens. Maintaining protocol adherence and appropriate clinical follow-up emerged as important practical issues. CONCLUSION: In Thai adults, ZDV 100 mg tid+200 mg nocte and ZDV 250 mg bid have similar clinical and immunological efficacy. Rates of ZDV toxicity are comparable to those reported in non-Asian populations. Despite limitations in medical care access and maintaining long-term follow-up, successful trials of antiretroviral agents are feasible in South-East Asia and multi-drug treatment trials should be pursued in appropriate institutions.

Adolescent↗

PubMed2003

Highly active antiretroviral therapy outcomes in a primary care clinic.

This paper compares antiretroviral outcomes of patients at a primary care clinic with those previously reported at HIV specialty clinics and examines risk factors for treatment failure. A retrospective medical record review was undertaken at an academic primary care practice in Baltimore, Maryland. One hundred and twenty-three patients were included who had not previously received HAART and who were started on a regimen that included a protease inhibitor or a non-nucleoside reverse transcriptase inhibitor and at least one other new antiretroviral medication. HIV RNA levels, CD4 lymphocyte counts, missed appointment rate, HAART regimen, demographic variables, and their association with the achievement of a viral RNA of 500 or less at 7-14 months were analyzed. Forty-seven per cent of the patients had an HIV RNA level of 500 or less at 7-14 months after initiation of HAART. Factors associated with treatment failure included missed appointment rate, injection drug use and previous exposure to antiretroviral medication. On multivariate analysis, only missed appointment rate and lower baseline CD4 lymphocyte count were independently associated with treatment failure. The antiretroviral outcomes of patients started on HAART by experienced health care providers in this primary care practice were comparable to those reported in specialty clinics. As with previous reports, most patients did not maintain viral suppression. Missed appointment rate was the most important risk factor for treatment failure.

Adult↗

PubMed1994

The effect of methadone on immunological parameters among HIV-positive and HIV-negative drug users.

Our objective was to assess the effects of methadone use on immune parameters. A convenience sample of men and women drug injectors who knew their HIV serostatus were enrolled in a longitudinal observational study of HIV illness. During analysis of baseline data, differences were noted in immune parameters among Methadone users. Study participants were recruited in Manhattan, New York, from a methadone maintenance clinic, and infectious disease clinic of an inner city hospital, and a drug-free community center. The participants were 220 men and women, current or former drug injectors, approximately half of them HIV-antibody positive and the rest HIV-antibody negative. Candidates with opportunistic infections and secondary neoplasms were excluded. Methadone users were compared to nonmethadone users for absolute and percentage counts of CD4, CD8, and activated T lymphocytes; CD4/CD8 ratio; an HIV symptom check list; and medical staging. The results discussed in this paper were formulated after data collection was complete. Our data indicate that methadone treatment, while not significantly affecting absolute CD4 lymphocyte count, is associated with a lower CD4 percentage and CD4/CD8 cell ratio, and with a higher CD8 absolute count and percentage. These differences are present regardless of HIV serostatus. Our findings should be interpreted with caution since we did not set out to investigate the effects of methadone on the immune system. Nevertheless, if it is corroborated that methadone has a detrimental effect on the immune system, finding alternatives to methadone-maintenance treatment for drug injectors will be a necessity.

Adult↗

PubMed2000

Declining prevalence of opportunistic gastrointestinal disease in the era of combination antiretroviral therapy.

OBJECTIVE: Opportunistic disorders (OD) are the most frequent GI manifestations of the acquired immunodeficiency syndrome (AIDS). Since the introduction of highly active antiretroviral therapy (HAART), there appears to be have been a reduction in the incidence of many of these OD; however, the effect of HAART on the prevalence of GI OD has not been well studied. METHODS: From 4/95 through 3/98, all HIV (HIV)-infected patients undergoing GI endoscopy were prospectively identified; mucosal biopsies were obtained in a standardized fashion and histological specimens were examined by a single GI pathologist. Patients were divided into three groups based on the time of evaluation: group I: 4/95 to 3/96; group II: 4/96 to 3/97; and group III: 4/97 to 3/98. RESULTS: A total of 166 patients (90% men; mean age 36+/-10 yr; median CD4 lymphocyte count 62 cells/microl, range 2-884, median viral RNA level 1,357 copies/ml, range undetectable to 7,721,715) underwent 279 upper and/or lower endoscopies during the study period. There were no statistical differences in patients' demographics and indications for endoscopy although the CD 4 lymphocyte count was higher in group III. The percentage of patients receiving HAART at the time of endoscopy increased from 0% to 57% over the three periods (p<0.01), and the percentage of patient receiving combination antiretroviral therapy increased from 37% to 82% over the study period (p<0.01). In contrast, the prevalence of OD decreased from 69% (group I) to 13% (group III) (p<0.01), whereas the prevalence of non-OD, including a normal endoscopy increased from 31% to 87% (p<0.01). CONCLUSIONS: GI OD now seem to be an uncommon problem in HIV-infected patients undergoing endoscopy despite a low CD4 lymphocyte count, and this reduction of OD was associated with the use of HAART.

AIDS-Related Opportunistic Infections↗

PubMed2001

18-Month mortality and perinatal exposure to zidovudine in West Africa.

OBJECTIVES: To study mortality in African children born to HIV-1-infected mothers exposed peripartum to zidovudine. METHODS: A randomized placebo-controlled trial in Abidjan and Bobo-Dioulasso. Pregnant women received either 300 mg zidovudine twice daily from 36-38 weeks' gestation, 600 mg during labour, and 300 mg twice daily for 7 days post-partum or a matching placebo. Determinants of mortality were studied up to 18 months, overall and among the infected children: treatment, centre, timing of infection, mother and child HIV disease. RESULTS: There were 75 infant deaths among 407 live births. The risk of death at 18 months was 176/1000 in the zidovudine arm and 221 for placebo. Relative hazard (RH, zidovudine versus placebo) was 0.47 [95% confidence interval (CI) 0.2-1.0] up to 230 days of life. Maternal CD4 lymphocyte count < 200/mm3 (RH 2.92; CI 1.4-6.1) and child HIV-1 infection (RH 12.6; CI 6.6-24.3) increased mortality of all children born to HIV-1-infected mothers. There were 101 children infected (40 in the zidovudine group), and 51 died. Their 18 month probability of death was 590/1000 in the zidovudine group and 510 in the placebo group. Among infected children, maternal zidovudine reduced the risk of death on or before day 230 (RH 0.18; CI 0.1-0.5). Maternal CD4 lymphocyte count < 200/mm3 (RH 3.25; CI 1.3-8.4), maternal death (RH 9.65; CI 1.7-56.0), diagnosis of paediatric infection on or before day 12 (RH 18.1; CI 4.8-69.0) and between days 13 and 45 (RH 7.63; CI 2.0-29.5), clinical paediatric AIDS (RH 5.37; CI 2.3-12.7) were risk factors for death in HIV-1-infected children. CONCLUSION: Mother-to-child transmission reduction by zidovudine is safe and beneficial to African children. The mortality of HIV-1-infected children is high. Peripartum maternal zidovudine exerts a protective effect for at least 8 months.

Adult↗

PubMed1999

Pain in ambulatory HIV-infected patients with and without intravenous drug use.

The prevalence of pain in 211 HIV-infected patients with and without intravenous drug use was assessed and the prognostic information inherent in pain reporting was evaluated, using a questionnaire on pain and HIV-related symptoms combined with data on disease classification, route of HIV transmission, CD4+ lymphocyte counts in blood (CD4) and mortality rates at 15 months after completing the questionnaire. The pain prevalence was significantly higher among intravenous drug users (IDUs) compared with non-IDUs [76/89 (85%) vs 87/122 (71%);p<0.05], especially among the patients classified as asymptomatic [43/53 (81%) vs 35/59 (59%);p = 0.01]. No significant difference was found among AIDS patients. In non-IDUs, a strong correlation was found between HIV disease stages according to the Centers for Disease Control classification (CDC) and pain prevalence (CDC A: 59%vs B: 74%vs C: 96%, p<0.001), and between the number of concurrent pain sites and both the CD4 levels (no pains: CD4 0.26 x 10(9)/l vs 1-2 pain sites: CD4 0.22 vs>2 pain sites: CD4 0.09;r = 0.35, p<0.001), and the mortality rate [no pains: 2/35 (6%) vs 1-2 pain sites: 8/45 (18%) vs> 2 pain sites: 12/42 (29%), p<0.01]. In IDUs, no such correlations were found. Our data demonstrates differences in the development, prevalence and prognostic value of pain among HIV-infected patients, with and without intravenous drug use, clearly indicating the need to differentiate risk groups in pain related studies. Copyright 1999 European Federation of Chapters of the International Association for the Study of Pain.

Journal Article↗

PubMed1995

Efficacy of antenatal zidovudine in reducing perinatal transmission of human immunodeficiency virus type 1. The New York City Perinatal HIV Transmission Collaborative Study Group.

New York City women (321) enrolled during 1986-1993 in an observational cohort study were analyzed retrospectively to determine the effectiveness of antenatal zidovudine in reducing perinatal transmission of human immunodeficiency virus type 1 (HIV-1) in women with various CD4+ lymphocyte counts (< 200, 200-499, > 499/microL). When CD4+ lymphocyte level was controlled for, women prescribed zidovudine during pregnancy were less likely to transmit HIV-1 to their infants (adjusted odds ratio, 0.36; 95% confidence interval, 0.14-0.92). There was no conclusive evidence that efficacy of zidovudine depended on CD4+ lymphocyte level, suggesting that women with severe CD4+ cell depression, who are at highest risk of transmitting HIV-1, may also benefit from zidovudine. Antenatal zidovudine treatment alone may substantially lower the risk of perinatal HIV-1 transmission. These data are consistent with the results of AIDS Clinical Trial Group protocol 076 and suggest that a substantial portion of zidovudine's protective effect may occur when used during the antenatal period.

CD4-CD8 Ratio↗

PubMed1998

[Mycobacterial lung infection in 8 patients with AIDS: clinical and radiological features].

The prevalence of mycobacterial infection in AIDS patients has increased in Japan. This report describes details of the clinical and radiological features of eight AIDS patients with mycobacterial disease (6 with M. tuberculosis infection and 2 with M. kansasii infection) in our hospital during the period from October 1995 through February 1997. Six of the 8 were men, and two were women. The mean age was 36.5 years. Six were Japanese, one was from Myanmar, and one was Malaysian. The median CD4 positive T lymphocyte counts (CD4 count) at the time of diagnosis of the M. tuberculosis was 75.5 (range 14-569/microliter, and the M. kansasii was 21.5 (range 19-24)/microliter. Clinical findings and symptoms of all patients were non-specific, but almost all patients had a cough and fever. In the radiographic findings, the patients of the M. tuberculosis group presented multiple hilar and mediastinal lymphadenopathy, miliary shadow, and obstructive pneumonia. Both M. kansasii patients showed a multiple infiltration shadow. There were no drug resistant strains in M. tuberculosis except on isolate with moderate resistant. to Streptomycin. These observations suggest that AIDS-associated mycobacterial disease shows atypical clinical and radiological features in some cases, especially in advanced stages of AIDS. Therefore, we need to recognize the characteristics of the clinical and radiological features of the patients with mycobacterial diseases and AIDS.

AIDS-Related Opportunistic Infections↗

PubMed2005

Oral combination chemotherapy in the treatment of AIDS-associated Hodgkin's disease.

OBJECTIVES: To determine the effectiveness of an oral combination chemotherapy regimen administered to patients with AIDS-associated Hodgkin's disease. DESIGN: Prospective, pilot phase II clinical trial. SETTING: Consecutive patient recruitment occurred at two medical centers in the United States: Albany Medical Center, Albany, New York, where patients were recruited prior to December 31, 1996 (pre-HAART era); and University Hospitals of Cleveland, Cleveland, Ohio, where patients were recruited after January 1, 1997 (HAART era). INTERVENTION: Oral chemotherapy consisted of lomustine (100 mg/m2 day I for cycle one and odd cycles thereafter); etoposide (200 mg/m2 days 1 through 3); and cyclophosphamide and procarbazine (each 100 mg/m2 days 22 through 31). Cycles were repeated every six weeks. Colony-stimulating factor support (G-CSF in all instances) was allowed. MAIN OUTCOME MEASURES: Clinical demographic variables, peripheral blood counts, serum chemistries, CD4 lymphocyte count, histopathological subtype of Hodgkin's disease were identified for all patients, who were staged according to Ann Arbor criteria. DATA ANALYSIS: Common Toxicity Criteria were utilized to assess safety; response was assessed using ECOG criteria; and survival was analyzed by Kaplan-Meier methods and difference of survival between pre-HAART and HARART era was compared using log-rank test. RESULTS: Eleven patients (six in pre-HAART era), all but one male, with a median age of 36 years, excellent performance status and advanced International Prognostic Score were treated. Myelosuppression was the major side effect and there were minimal other grade 3 or greater toxicity all of which were promptly reversible. An overall objective response rate of 82% (with 18% complete responses) and median survival duration of 24 months (range 2.5 +/- 68) were observed. Survival was markedly improved in patients treated in the HAART era (median not reached versus 7.25 months, p = 0.034). CONCLUSIONS: This feasibility study demonstrates acceptable tolerance and excellent clinical activity of oral combination chemotherapy in patients with AIDS-associated Hodgkin's disease. Improved survival is observed in combination with HAART therapy. Dose-modification of this regimen would be suitable to evaluate in the resource constrained setting and larger confirmatory studies are encouraged.

Adult↗

PubMed1994

MT-2 cell tropism as prognostic marker for disease progression in human immunodeficiency virus type 1 infection.

The ability of human immunodeficiency virus type 1 (HIV-1) isolates to replicate in MT-2 cells was investigated as a prognostic marker for disease progression and CD4+ lymphocyte depletion in 53 HIV-1-infected, asymptomatic individuals. MT-2-negative viruses were isolated from 49% of the patients both early and late during the follow-up period; 38% converted from being MT-2 negative to MT-2 positive, while 11% were MT-2 positive throughout the study. One individual showed a fluctuating virus phenotype. The loss of CD4+ lymphocytes was significantly more rapid in MT-2-positive patients. We found a broad spectrum of CD4+ lymphocyte changes in patients whose virus changed its MT-2 tropism. Our data suggest that the changes could be divided into three general patterns. A stable or slowly decreasing CD4+ lymphocyte count changed into a more rapid fall in 44% of the patients, no significant change in rate of decline could be noted in 44% of the patients, while a stable CD4+ lymphocyte level after a change in MT-2 tropism was noted in 12% of the patients. A correlation between MT-2 tropism and clinical symptoms was also noted. Half of the patients with MT-2-negative virus throughout the study were still asymptomatic after a mean follow-up time of 80 months, while only 15% of those who converted remained asymptomatic. All patients with MT-2-positive viruses at the time of inclusion in the study developed HIV-1-related symptoms, and half of them died during the study. The MT-2 status of 16 patients, could be determined at the time of AIDS diagnosis; 50% were Mt-2 positive, while 50% were MT-2 negative. No difference in AIDS-defining diagnoses or CD4+ lymphocyte counts at the time of diagnosis was noted. Knowledge of the HIV-1 phenotype may improve the early recognition of progressive disease.

Adult↗

PubMed1998

Randomised placebo-controlled trial of ritonavir in advanced HIV-1 disease. The Advanced HIV Disease Ritonavir Study Group.

BACKGROUND: Ritonavir is a potent, orally bioavailable inhibitor of HIV-1 protease. We undertook an international, multicentre, randomised, double-blind, placebo-controlled trial of ritonavir in patients with HIV-1 infection and CD4-lymphocyte counts of 100 cells/microL or less, who had previously been treated with antiretroviral drugs. METHODS: 1090 patients were randomly assigned twice-daily liquid oral ritonavir 600 mg (n = 543) or placebo (n = 547) while continuing treatment with up to two licensed nucleoside agents. The primary study outcome was any first new, or specified recurrent, AIDS-defining event or death. Open-label ritonavir was provided after 16 weeks in the study to any patient who had an AIDS defining event. FINDINGS: The baseline median CD4-lymphocyte count was 18 (IQR 10-43)/microL in the ritonavir group and 22 (10-47)/microL in the placebo group. Study medication was discontinued in 114 (21.1%) ritonavir-group patients and 45 (8.3%) placebo-group patients mainly because of initial adverse symptoms. Outcomes of AIDS-defining illness or death occurred in 119 (21.9%) ritonavir-group patients and 205 (37.5%) placebo-group patients (hazard ratio 0.53 [95% CI 0.42-0.66]; log-rank p < 0.0001) during median follow-up of 28.9 weeks, with loss to follow-up of 15 (1.4%) patients. Ritonavir was then offered to all patients; at median follow-up of 51 weeks, 87 (16%) ritonavir-group patients had died of any cause versus 126 (23%) placebo-group patients (hazard ratio 0.69 [95% CI 0.52-0.91], log-rank p = 0.0072). INTERPRETATION: Although earlier intervention with combination therapy may provide much more effective treatment, ritonavir in patients with advanced disease and extensive previous antiretroviral use is safe and effective, lowers the risk of AIDS complications, and prolongs survival.

Acquired Immunodeficiency Syndrome↗

PubMed2001

Detrimental effects of continued illicit drug use on the treatment of HIV-1 infection.

OBJECTIVE: To identify the effects of substance abuse status (active, former, and never) on utilization of highly active antiretroviral therapy (HAART), medication adherence, and virologic and immunologic responses to therapy. DESIGN: Prospective cohort study of 764 HIV-1-infected patients who attended an urban HIV clinic and participated in a standardized interview. MAIN OUTCOME MEASURES: Past utilization of HAART, self-reported nonadherence with antiretroviral therapy, and changes in HIV-1 RNA level and CD4+ lymphocyte count relative to prior peak and nadir, respectively. RESULTS: Forty-four percent of active drug users failed to utilize HAART compared with 22% of former drug users and 18% of non-drug users (p <.001 for both comparisons). Among participants who were taking antiretroviral therapy when interviewed, active drug users were more likely to report medication nonadherence (34% vs. 24% of nonusers and 17% of former users), had a smaller median reduction in HIV-1 RNA from baseline (0.8 log10 copies/ml vs. 1.7 in nonusers and 1.6 in former users), and had smaller median increases in CD4+ lymphocyte count from baseline (65 cells/mm3 vs. 116 in nonusers and 122 in former users) (p <.05 for all comparisons with active users). CONCLUSIONS: Active drug use was strongly associated with underutilization of HAART, nonadherence, and inferior virologic and immunologic responses to therapy, whereas former drug users and non-drug users were similar in all outcomes. Effective strategies are needed that integrate HIV-1 and substance abuse treatments.

Adult↗

PubMedDate not supplied

Co-infection by Cryptococcus neoformans and Mycobacterium avium intracellulare in AIDS. Clinical and epidemiological aspects.

In the observation of various opportunistic pathogens in HIV-positive persons, co-infection by Cryptococcus neoformans together with Mycobacterium avium intracellulare was found if there was a CD4 lymphocyte count as low as 3-20/microliters. In 1540 HIV-positive patients under treatment at a Berlin hospital (Auguste-Viktoria-Krankenhaus) during 1985-1994, all AIDS-relevant diseases were examined in a multivariate analysis as variables of influence on the manifestation of a systemic Mycobacterium avium complex (MAC) infection. The analysis involved data on 36 cases of cryptococcosis and 202 cases with a typical clinical course in whom MAC had been detected at sterile body sites. As significant and independent factors of influence, the following were identified: C. neoformans infection, wasting syndrome, lower age, low CD4 lymphocyte count and preceding Pneumocystis carinii pneumonia (PcP) prophylaxis. Cryptococcosis ranged first with an ods ratio of 2.75. The concomitant manifestation of cryptococcosis and systemic MAC infection in six patients is shown. Because both opportunists, C. neoformans and avian mycobacteria, may have their common habitat in droppings of defined species of pet birds, a common source of infection deserves further clinical and epidemiological attention.

AIDS-Related Opportunistic Infections↗

PubMed1995

Lymphocyte subset counts in skin puncture and venous blood compared.

To determine whether skin puncture blood can be used reliably for CD4 lymphocyte counts, the numbers of the major subsets of lymphocytes were assessed in paired venous and skin puncture blood samples from 22 children and 10 adults. Paired values were highly correlated, with skin puncture values being about 7% higher than venous values for each cell type. Differences were of borderline statistical significance for total lymphocytes and for each subset except CD3+ CD8+ T lymphocytes. Nevertheless, the magnitude of the differences was small and unlikely to be of clinical importance, and it seems that skin puncture samples may be preferable for CD4 counts in children or adults with difficult venous access.

Acute Disease↗