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S Emery

Publications and source records attributed to S Emery.

At least 19 recordsLinked to original sources
PubMed2006

CD4+ count-guided interruption of antiretroviral treatment.

BACKGROUND: Despite declines in morbidity and mortality with the use of combination antiretroviral therapy, its effectiveness is limited by adverse events, problems with adherence, and resistance of the human immunodeficiency virus (HIV). METHODS: We randomly assigned persons infected with HIV who had a CD4+ cell count of more than 350 per cubic millimeter to the continuous use of antiretroviral therapy (the viral suppression group) or the episodic use of antiretroviral therapy (the drug conservation group). Episodic use involved the deferral of therapy until the CD4+ count decreased to less than 250 per cubic millimeter and then the use of therapy until the CD4+ count increased to more than 350 per cubic millimeter. The primary end point was the development of an opportunistic disease or death from any cause. An important secondary end point was major cardiovascular, renal, or hepatic disease. RESULTS: A total of 5472 participants (2720 assigned to drug conservation and 2752 to viral suppression) were followed for an average of 16 months before the protocol was modified for the drug conservation group. At baseline, the median and nadir CD4+ counts were 597 per cubic millimeter and 250 per cubic millimeter, respectively, and 71.7% of participants had plasma HIV RNA levels of 400 copies or less per milliliter. Opportunistic disease or death from any cause occurred in 120 participants (3.3 events per 100 person-years) in the drug conservation group and 47 participants (1.3 per 100 person-years) in the viral suppression group (hazard ratio for the drug conservation group vs. the viral suppression group, 2.6; 95% confidence interval [CI], 1.9 to 3.7; P<0.001). Hazard ratios for death from any cause and for major cardiovascular, renal, and hepatic disease were 1.8 (95% CI, 1.2 to 2.9; P=0.007) and 1.7 (95% CI, 1.1 to 2.5; P=0.009), respectively. Adjustment for the latest CD4+ count and HIV RNA level (as time-updated covariates) reduced the hazard ratio for the primary end point from 2.6 to 1.5 (95% CI, 1.0 to 2.1). CONCLUSIONS: Episodic antiretroviral therapy guided by the CD4+ count, as used in our study, significantly increased the risk of opportunistic disease or death from any cause, as compared with continuous antiretroviral therapy, largely as a consequence of lowering the CD4+ cell count and increasing the viral load. Episodic antiretroviral therapy does not reduce the risk of adverse events that have been associated with antiretroviral therapy. (ClinicalTrials.gov number, NCT00027352 [ClinicalTrials.gov].).

AIDS-Related Opportunistic Infections↗
PubMed2006

Intravesical oxybutynin: practicalities of clinical use.

Oral anticholinergic therapy, used for the treatment of detrusor overactivity (DO), is limited by systemic side-effects and because of failure to respond. Alternative routes of administration include the intravesical route. We reviewed 11 women who were treated with intravesical oxybutynin (IVO). All had idiopathic DO, their symptoms having been unsuccessfully controlled on oral agents. Seven patients had symptomatic improvement. Six out of the eight patients that completed their voiding diaries showed a reduction in voiding frequency. Five patients found the procedure too inconvenient. Seven patients suffered chemical irritation. One patient complained of voiding difficulties. No patient reported systemic side-effects. The mean duration of treatment was 4-5 weeks; two patients continue to use IVO. IVO can be used successfully in the treatment of DO, but its use is limited due to the inconvenience related to catheterisation. With the advent of Botox and oxybutynin patches, IVO probably has a limited role.

Administration, Intravesical↗
PubMed2006

Minor changes in calculated creatinine clearance and anion-gap are associated with tenofovir disoproxil fumarate-containing highly active antiretroviral therapy.

BACKGROUND: Tenofovir disoproxil fumarate (Tenofovir DF, TDF), the first nucleotide reverse transcriptase inhibitor approved for the treatment of HIV disease, has been associated with renal dysfunction in isolated cases. The aim of this study was to assess changes in renal parameters in individuals receiving TDF- and non-TDF-containing highly active antiretroviral therapy (HAART). METHODS: All individuals on HAART attending our clinic were included in the analysis. Time-weighted changes in serum creatinine, calculated creatinine clearance (CCrCl) and anion-gap were assessed for individuals on TDF- and non-TDF HAART. RESULTS: Of 948 individuals on HAART, 290 (31%) and 618 (65%) were on TDF- and non-TDF HAART, with 40 (4%) having ceased TDF HAART. Baseline values for serum creatinine, CCrCl and anion-gap were similar for those on TDF- and non-TDF HAART. In a multivariate analysis, statistically significant differences were observed in time-weighted change from baseline in anion-gap and CCrCl between individuals on TDF- and non-TDF HAART [mean difference in change between groups: anion-gap 0.78 mmol/L (standard error, 0.19) and CCrCl-6.80 (standard error 2.2); P = 0.005 and P = 0.032, respectively] after adjusting for baseline anion-gap and CCrCl, respectively. Two cases of TDF-associated renal failure were observed. CONCLUSION: Overt renal failure with TDF HAART is rare. However, subtle but statistically significant changes in anion-gap and CCrCl were observed which were associated with TDF HAART. These parameters may be of use in monitoring individuals on HAART.

Acid-Base Equilibrium↗
PubMed2005

Randomized, placebo-controlled, phase I/IIa evaluation of the safety and immunogenicity of fowlpox virus expressing HIV gag-pol and interferon-gamma in HIV-1 infected subjects.

We conducted a randomized, placebo-controlled double-blind trial to examine the safety and immunogenicity of a candidate HIV therapeutic vaccine based upon a recombinant fowl pox virus capable of coexpressing the human cytokine interferon-gamma and/or genes from HIV-1. Thirty-five eligible subjects were randomized (12 placebo, 11 fowlpox + HIV genes, 12 fowl pox + HIV genes + interferon gamma). All but one subject (placebo group) received three immunizations (by intramuscular injection on day 0, week 4 and week 12) and all completed 52 weeks of follow-up. All subjects continued to take combination antiretroviral therapy for the duration of study. There were no significant toxicity or safety concerns and the distribution of adverse events and their severity was consistent across each randomly assigned vaccine group. Comparison of placebo recipients with the combined recipients of the two vaccine constructs, in terms of anti-HIV gag ELISpot or lymphoproliferative responses, tended to favour the placebo group, but were not significantly different (difference in time-weighted mean change from baseline = 56 Spot forming units (sfu)/10(6) PBMC; p = 0.062 and 4.4 SI; p = 0.337). There were no significant changes in CTL responses by standard Cr(51) release assay. Anti-FPV antibodies were detected by week 14 in 0 placebo and 20 (87%) vaccine recipients. Although safe, neither vaccine construct appeared to possess detectable T-cell mediated anti-HIV immunogenic properties in HIV infected individuals, as measured by standard T cell assays.

AIDS Vaccines↗
PubMed2004

Are obstetric risk factors and bowel symptoms associated with defaecographic and manometric abnormalities in women awaiting hysterectomy?

Abdominal hysterectomy has been shown to affect anorectal function. These studies are either population-based or have been performed retrospectively. It is not clear from the literature whether those subjects awaiting hysterectomy already have an element of pelvic floor failure and which may be related to obstetric risk factors. A complete anorectal assessment was performed in a group of women awaiting hysterectomy who did not volunteer any bowel symptoms. The patients studied were part of an ongoing study of the functional effects of abdominal hysterectomy. All had their anorectal function assessed before their respective surgery by a questionnaire (functional bowel score), Cleveland continence score, endoanal ultrasound (U/S), anal manometry, defaecatory proctogram and colonic transit. A detailed obstetric history, which included risk factors such as parity, type of delivery, duration of labour and elevated birth weight, were also recorded. Patients with previous bowel disease, bowel surgery and anal sphincter repair were excluded. There were 39 subjects with a median age of 43 years (range 31-65), respectively. Thirty-three rectocoeles and 22 intussusceptions were demonstrated. Two had poor puborectalis function, while five had cough incontinence. Two women had abnormal colonic transit. Thirteen had abnormal anal manometry. Endoanal ultrasound was normal in all patients. None of the obstetric risk factors were associated with rectocoele, intussusception or abnormal anal manometry. Low squeeze pressure was associated significantly with more bowel symptoms (P=0.03). However, rectocoele, intussusception, abnormal colonic transit, abnormal resting anal pressure and maximal tolerated volume were not statistically significantly associated with bowel symptoms. The majority of female subjects who were awaiting hysterectomy had physiological and proctographic abnormalities consistent with pelvic floor failure. Obstetric risk factors were not associated with rectocoele, intussusception, abnormal colonic transit and anal manometry in this cohort of patients. Similarly, the majority of proctographic abnormalities were not associated with bowel symptoms. However, a trend was noted associating bowel symptoms with manometric abnormalities.

Adult↗
PubMed2003

An objective case definition of lipodystrophy in HIV-infected adults: a case-control study.

BACKGROUND: Lipodystrophy (peripheral lipoatrophy, central fat accumulation, and lipomatosis) is a common and disfiguring problem in adult patients with HIV-1 infection on antiretrovirals. However, an objective, validated definition of the disorder does not exist. We aimed to develop an objective, sensitive, specific, and broadly applicable case definition of HIV lipodystrophy. METHODS: In a case-control study, 1081 consecutive, HIV-infected, adult outpatients (261 [15%] women) without active AIDS were recruited from 32 sites worldwide. We classed patients with at least one moderate or severe subjective lipodystrophic feature, identified by lipodystrophy-specific physical examination and patient questionnaire, and apparent to both doctor and patient as cases (n=417). We classed patients with no such feature as controls (n=371), and patients without a clear diagnosis as non-assigned. We used objective clinical, metabolic, and body composition measurements to construct a logistic regression model with a subset of randomly selected cases and controls. The model was validated in the remaining patients. FINDINGS: A model including age, sex, duration of HIV infection, HIV disease stage, waist to hip ratio, anion gap, serum HDL cholesterol concentration, trunk to peripheral fat ratio, percentage leg fat, and intra-abdominal to extra-abdominal fat ratio had 79% (95% CI 70-85) sensitivity and 80% (95% CI 71-87) specificity for diagnosis of lipodystrophy. Models that incorporated only clinical, or only clinical and metabolic variables had lower sensitivity and specificity than the inclusive model. Models for lipoatrophy, fat accumulation, and lipomatosis could not be developed since pure phenotypes occurred in fewer than 10% of patients with clinical diagnoses of these disorders. INTERPRETATION: Our objective case definition of HIV-associated lipodystrophy should improve assessment of lipodystrophy prevalence, risk factors, and pathogenesis; prevention and treatment approaches; and assist in diagnosis.

Adult↗
PubMed2003

Intratumoral expression of a fusogenic membrane glycoprotein enhances the efficacy of replicating adenovirus therapy.

We describe here a novel strategy to enhance the in vivo efficacy of replicating adenovirus therapy, using coinjection of plasmid DNA encoding a fusogenic viral glycoprotein. The combination of fusogenic membrane glycoprotein (FMG)-induced tumor cell fusion and infection with replicating adenovirus effectively treats even large established tumors at doses of plasmid DNA and virus that alone are ineffective. Adenoviral infection appears to increase the transduction of the tumor cells to a modest degree thereby boosting the FMG-mediated component of the therapy. Simultaneously, syncytial formation enhances the therapeutic effects of viral infection by increasing spread of adenoviral particles through the tumor cell population and by increasing titer of virus released from the tumor cells. This effect is due probably to release of intracellular viral particles upon tumor cell death and also to increased levels of E1A protein within syncytia, whose increased metabolic rate is associated with enhanced levels of protein expression. Cotransduction of tumor cells with replicating adenovirus and FMG-expressing vectors could either be combined within single replicating vectors or could be used in strategies using separate administration of two components, both at lower doses than required for either therapy alone.

Adenoviridae↗
PubMed2003

HIV lipodystrophy: prevalence, severity and correlates of risk in Australia.

OBJECTIVE: To establish the prevalence, severity and factors associated with the HIV lipodystrophy syndrome. METHODS: Cross-sectional study of lipodystrophy conducted in high HIV caseload primary care sites and HIV outpatient clinics. A subset of patients was examined using dual energy X-ray absorptiometry (DEXA) and single cut abdominal computerized tomography (CT) at the L4 vertebral level to quantify regional and total body fat. Factors associated with lipodystrophy, lipoatrophy and lipohypertrophy were assessed using multiple logistic regression based on assignment of cases and non-cases. RESULTS: One thousand, three hundred and forty-eight patients (95% male) were surveyed, 20% had AIDS, the mean CD4 lymphocyte count was 486 cells/microL, and 55% had <500 HIV-1 RNA copies/mL. Most participants (87%) had previously received or were currently receiving combination antiretroviral therapy, 73% with at least one protease inhibitor (PI) and 14% a non-PI-containing regimen. Lipodystrophy prevalence was 53% and of these, 55% reported both peripheral lipoatrophy and central lipohypertrophy, 31% experienced peripheral lipoatrophy only and 14% had central lipohypertrophy only. The prevalence of any body habitus change was 62% in PI-experienced patients, 33% in PI-naive patients and 21% in antiretroviral-naive patients. Lipodystrophy severity was less in antiretroviral-naive patients and most severe in PI-experienced patients. Increasing severity of lipodystrophy was both positively and significantly correlated with elevated liver enzymes, decreased testosterone levels, decreased skin-fold thickness, lower levels of total and peripheral fat (DEXA) and higher levels of visceral fat (CT). Lipodystrophy was also significantly associated with increasing age, symptomatic HIV disease, effective viral suppression, and increasing duration of therapy with both nucleoside reverse transcriptase inhibitors and PIs. CONCLUSIONS: The prevalence and severity of lipodystrophy reflects both length and type of treatment with antiretroviral therapy and is associated with decreased testosterone, increases in liver enzymes and greater suppression of HIV RNA. The reports of lipodystrophy in a small percentage of antiretroviral-naive patients suggests that factors other than antiretroviral therapy may be involved in the aetiology of this syndrome or that some conditions, such as wasting or age-associated obesity, may mimic lipoatrophy and lipohypertrophy, respectively.

Absorptiometry, Photon↗
PubMed2003

Quality assessment program for genotypic antiretroviral testing improves detection of drug resistance mutations.

Genotypic antiretroviral testing is now widely used for the management of patients who are undergoing antiretroviral therapy for human immunodeficiency virus infection. The assays are complex, and there is considerable potential for variation between laboratories. Informative and ongoing quality assessment programs (QAPs) which address all aspects of testing are required. The panel distribution of clinical material is a critical component of QAPs. We report on the results and data from a recent panel. Four cryopreserved plasma samples from treated donors were distributed to nine laboratories. Three laboratories performed testing by commercial assays, and six laboratories used in-house assays, with one laboratory reporting results from two in-house assays. There was complete concordance between results for 95.9% of the nucleotide sequence and 94.5% of the amino acid sequence. Despite this overall high level of concordance, the degree of concordance at drug resistance mutation (DRM) sites when DRMs were present was considerably less (38% of DRM sites). Consequently, only 3 of the 10 methods reported 100% of DRMs as present. This elevated discrepancy rate is almost certainly a result of variability in the identification of mixtures of nucleotides (mixtures) at any site within the sequence. In addition, laboratories differed in the number of codons in the reverse transcriptase gene that were sequenced and their ability to amplify all samples. This panel distribution demonstrated a requirement for laboratory participation in ongoing QAPs and the optimization of assays with standards that contain mixtures.

Anti-HIV Agents↗
PubMed2003

Appraisal of anti-smoking advertising by youth at risk for regular smoking: a comparative study in the United States, Australia, and Britain.

OBJECTIVE: To compare the similarity in how youth in the United States, Australia, and Britain appraise anti-smoking advertisements with different characteristics. DESIGN: Each participant viewed and evaluated a set of 10 anti-smoking adverts (from an overall total of 50 adverts) in a controlled experimental context using an audience response methodology. A structured telephone interview was completed one week after viewing the adverts, in which recall and engagement with the adverts by participants was evaluated. SUBJECTS: 615 youths who were experimenting with smoking or were susceptible nonsmokers. MAIN OUTCOME MEASURES: Measures of advert appraisal and engagement. RESULTS: Youth in the United States, Australia, and Britain responded in very similar ways to the same anti-smoking advertisements. In full multivariate models, the target audience of the advert and the advert theme were not related to the main outcome measures employed in this study. However, adverts with visceral negative or personal testimonial executional characteristics were appraised more positively by youths and were more likely to be recalled, thought about, and discussed at follow up one week later. CONCLUSIONS: Youths in three different countries responded to anti-smoking advertisements in very similar ways, suggesting that such adverts might be more actively shared among nations. The appraisal of, and engagement with, the anti-smoking adverts, however, varied substantially depending on executional characteristics. In the design of effective anti-smoking adverts, due attention needs to be paid to those characteristics that appear to most engage youth across different social and cultural environments.

Adolescent↗
PubMed2003

Chlamydia trachomatis infection in a colposcopy unit: an audit of a fast track referral system for infected patients to a genitourinary medicine department and a survey of patients' demography, clinical findings and partner details.

We had previously shown that screening and treating patients for Chlamydia trachomatis prior to termination of pregnancy significantly reduces postoperative morbidity. Our success led us to consider screening women attending our colposcopy unit and this was introduced in 1998. However, it became apparent that a formal protocol was needed for managing women who had positive results to ensure that all patients and their partners were adequately treated. An interdepartmental protocol was devised for fast track referral of infected patients to the Genitourinary Medicine (GUM) clinic Health Advisor who arranged immediate treatment and partner notification. A re-audit, presented here, has shown that the introduction of the protocol has resulted in all infected patients receiving adequate treatment and partner notification with minimal use of doctor time or disruption of routine GUM services. We suggest that our system is effective and could be extended to other clinics where chlamydia screening is carried out.

Adolescent↗
PubMed2002

Was there significant tax evasion after the 1999 50 cent per pack cigarette tax increase in California?

OBJECTIVES: Several states, including California, have implemented large cigarette excise tax increases, which may encourage smokers to purchase their cigarettes in other lower taxed states, or from other lower or non-taxed sources. Such tax evasion thwarts tobacco control objectives and may cost the state substantial tax revenues. Thus, this study investigates the extent of tax evasion in the 6-12 months after the implementation of California's 0.50 dollars/pack excise tax increase. DESIGN AND SETTING: Retrospective data analysis from the 1999 California Tobacco Surveys (CTS), a random digit dialled telephone survey of California households. MAIN OUTCOME MEASURES: Sources of cigarettes, average daily cigarette consumption, and reported price paid. RESULTS: Very few (5.1 (0.7)% (+/-95% confidence limits)) of California smokers avoided the excise tax by usually purchasing cigarettes from non- or lower taxed sources, such as out-of-state outlets, military commissaries, or the internet. The vast majority of smokers purchased their cigarettes from the most convenient and expensive sources: convenience stores/gas (petrol) stations (45.0 (1.9)%), liquor/drug stores (16.4 (1.6)%), and supermarkets (8.8 (1.2)%). CONCLUSIONS: Despite the potential savings, tax evasion by individual smokers does not appear to pose a serious threat to California's excise tax revenues or its tobacco control objectives.

Adolescent↗
PubMed2001

Does cigarette price influence adolescent experimentation?

The economics literature generally agrees that state and federal excise taxes can play an important role in deterring adolescent smoking. Teens' apparent responsiveness to cigarette prices is puzzling, since the majority of adolescent smokers do not buy their cigarettes. Teens typically do not begin to purchase cigarettes until they have developed an established pattern of smoking. Previous studies have not had adequate measures of smoking experience to explore whether adolescents' price responsiveness may vary by smoking experience. This paper uses data from a 1993 national survey of youth smoking to explore this hypothesis.

Adolescent↗
PubMed2001

Simulated effect of tobacco tax variation on Latino health in California.

BACKGROUND: Over one fourth of the California population was Latino in 1999, and by 2015 Latinos are expected to be the single largest ethnic group in California. Patterns of smoking and nicotine dependence among Latino smokers may be quite different from those of smokers in other ethnic groups. In addition, Latino smokers may be more sensitive to cigarette prices. Therefore, the effect of an increase in cigarette excise taxes on Latino smoking prevalence may be quite large, and consequently the impact on Latino health may be proportionately greater than on population health in general. METHODS: We simulated changes in Latino smoking, morbidity, mortality, and quality-adjusted life years (QALYs) that would result from a range of actual and proposed cigarette excise-tax increases using a range of cigarette price-elasticity estimates specific to Latino smokers. Monte Carlo simulation was used to generate confidence intervals. RESULTS: Assuming a Latino price elasticity of demand for cigarettes of -1.0, reductions in Latino smoking resulting from an additional $0.50/pack tax would produce nearly 3000 Latino QALYs in California in 1999. Greater benefits would accrue each year, until a steady state relative to population size is reached 75 years after the program is initiated. CONCLUSIONS: If Latino smokers are more responsive to changes in cigarette prices than other smokers, Latino smokers also stand to gain a disproportionate share of the health benefit from an excise tax increase.

California↗
PubMed2001

Immunomodulators as adjunctive therapy for HIV-1 infection.

BACKGROUND: There is renewed interest in the use of immunotherapy as an adjunct to antiretrovirals (ART) in the treatment of HIV disease. Most work has been performed on interleukin-2 (IL-2). There is considerable evidence from numerous phase II studies that intermittent dosing of subcutaneous IL-2 plus antiretroviral therapy (ART) produces a sustainable rise in the CD4(+) T-lymphocyte count which exceeds that which can be achieved using ART alone, without any adverse effect on plasma HIV RNA. However, the immunological competency and therefore clinical impact of this expanded CD4(+) T cell pool is yet to be established; this question is the focus of two large clinical end-point studies, ESPRIT and SILCAAT. OBJECTIVE: Prior to the establishment of ESPRIT, four 'Vanguard' studies were undertaken; the UK Vanguard examined the safety and virological/immunological aspects of intermittent subcutaneous IL-2 without the use of ART in HIV-1 ART naïve patients with a baseline CD4(+) T cell count of > or = 350cells/mm(3). DESIGN: The UK Vanguard was an open-label, randomised study comparing subcutaneous (s/c) IL-2 at either 4.5MIU or 7.5MIU q12h for 5 days every 8 weeks versus no therapy in HIV-1-infected individuals. Primary endpoints included mean area under the curve change from baseline CD4(+) T cell count and plasma log HIV-RNA. RESULTS: Thirty six subjects were enrolled into the three arms of the UK Vanguard study. Results showed significant differences in the area under the curve (AUC) change from baseline CD4(+) T cell count (P = 0.001) and changes in mean absolute CD4(+) T cell count (P = 0.04) and no significant difference in mean AUC change from baseline plasma HIV-RNA (P = 0.48) at 24 weeks between the IL-2 and control arms respectively. The significance of these results and those from other studies on the use of IL-2 in HIV disease are discussed.

Adjuvants, Immunologic↗
PubMed2000

A randomized, controlled 24-week study of intermittent subcutaneous interleukin-2 in HIV-1 infected patients in Thailand.

OBJECTIVES: To assess the immunological and virological effects, safety profile and feasibility of subcutaneous interleukin-2 (scIL-2) therapy in an HIV-infected Thai population. DESIGN: Seventy-two patients with baseline CD4 cell count of > or = 350 x 10(6)/l and no history of opportunistic infection were randomized to receive antiretroviral therapy plus scIL-2 (scIL-2 group) or antiretroviral therapy alone (control group). scIL-2 was administered at one of three doses for at least 24 weeks. The main measure of treatment efficacy was change in CD4 cell count. RESULTS: The time-weighted mean change in CD4 cell count from baseline to week 24 was + 252 x 10(6)/l for the scIL-2 group compared with + 42 x 10(6)/l for the control group (P< 0.0001). Changes in plasma HIV RNA were not significantly different between the groups over the same time period: there was a 0.83 log10 copies/ml decrease for the scIL-2 group and a 0.70 log copies/ml decrease for the control group (P= 0.362). CONCLUSIONS: This study provides the most extensive experience of scIL-2 therapy in HIV-1 infected women and Asians, and demonstrates the immunological efficacy, tolerability and feasability of scIL-2 therapy in this population. Data from this study were instrumental in guiding the selection of the scIL-2 dosing regimen for ongoing phase III trials.

Adult↗
PubMed2000

Pooled analysis of 3 randomized, controlled trials of interleukin-2 therapy in adult human immunodeficiency virus type 1 disease.

We collected human immunodeficiency virus (HIV) disease progression, survival, most recent CD4 cell count, and plasma HIV RNA levels from patients (n=157) who participated in randomized clinical trials of interleukin (IL)-2 that commenced before 1995. Data were available for 155 (99%) patients. Statistical analyses were based on the intention-to-treat principle. Median follow-up was 28 months and 30 months for control and IL-2 patients, respectively. Twenty-five (16%) patients developed AIDS or died during follow-up (16 control patients vs. 9 IL-2 patients; R2=0.57; P=.22). Mean change from baseline CD4 cell count was significantly higher in patients randomized to receive IL-2 (368 vs. 153 cells/microL; P=.003). Mean change from baseline plasma HIV RNA was significantly lower in patients randomized to receive IL-2 (-0.98 vs. -0.63 log copies/mL; P=.004). Significant improvements in CD4 cell count and plasma HIV RNA in recipients of IL-2 relative to control patients were associated with a nonsignificant trend toward improved clinical outcome.

Adult↗