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CPCRA Cross- Protocol Articles
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Cross-Protocol Articles as a PDF File
Gibert C, Bartsch G, El-Sadr W, Shlay J, Peng
G, Wang J, Visnegarwala F, Carr A,
Raghavan S. Association between stage of HIV disease and self-perceived
changes in body appearance. Int J Body Comp Res December 2005;3(4):133-129.
Editorial included.
This article is available
as a PDF File
Many HIV-infected patients report a change in body appearance.
A 'Change in Body Appearance' questionnaire, previously validated,
was used to assess self-perceived changes in body appearance over
the four months before enrollment into a clinical trial of antiretroviral-naïve
HIV-infected patients. Seven hundred seventy-nine patients completed
the questionnaire. Associations by gender, age, race, prior AIDS-defining
illness, log10 HIV RNA, and CD4+ lymphocyte count, with self-perception
of changes in body size at seven sites, were determined. Median
age was 38 years, 54% were African-American, 21.2% women, and 40%
had a prior AIDS-defining illness. A higher proportion of men reported
thinning of the arms, while a higher proportion of women reported
a decrease in size of breast and buttocks. Comparing men with or
without a prior AIDS-defining illness, those with a prior AIDS diagnosis
reported a higher frequency of thinning at six sites. For men, prior
AID diagnosis and a lower CD4+ lymphocyte count were independently
associated with perceived loss of body size at six sites. While
for women no association with prior AIDS was noted and a lower CD4+
lymphocyte count was only associated with smaller buttocks. With
advanced HIV disease, men and women had different perceptions of
change in body appearance. Overall, the questionnaire identified
changes in body appearance for men and would be clinically useful
to monitor self-perceived changes in body appearance of antiretroviral-naïve
men.
Tedaldi EM, Chen L, Markowitz N, Kelly L, Abrams D, the CPCRA Hepatitis Working Group. Effect of IL-2 on hepatitis C virus RNA levels in patients co-infected with human immunodeficiency virus receiving HAART. J Viral Hepat 2005 July; 12(4):414-20.
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The effect of interleukin-2 (IL-2) on the plasma levels of hepatitis C RNA (HCV-RNA) has varied in published reports. We measured the impact of IL-2 on plasma HCV RNA levels in 54 human immunodeficiency virus (HIV)/HCV coinfected patients enrolled in a randomized trial of 512 participants designed to compare the virologic and immunologic effects of cycled IL-2 plus antiretroviral therapy (ART) vs ART alone in the treatment of HIV in patients with CD4 cell counts >/=300 cells/mm(3). The mean decreases in average HCV RNA levels (copies/mL, log (10)) were 0.28 log in the IL-2 group (n = 26) and 0.04 log in the ART alone group (n = 28) at 12 months (P = 0.18). The changes in HCV RNA level were not associated with baseline or nadir CD4 cell counts, baseline aspartate aminotransferanse, CD4 cell response to IL-2, or changes in plasma HIV RNA values. Compared with those participants who only had HIV, the HIV/HCV co-infected patients did not have a significantly different CD4 cell response to IL-2 therapy. Intermittent IL-2 therapy does not produce a significant sustained decrease in plasma HCV RNA levels among patients co-infected with HIV/HCV who are on highly active ART.
Visnegarwala F, Chen L, Raghavan S, Tedaldi E for the Terry Beirn Community Programs for Clinical Research on AIDS. Prevalence of diabetes mellitus and dyslipidemia among antiretroviral naive patients co-infected with hepatitis C virus (HCV) and HIV-1 compared to patients without co-infection. J Infection 2005; 50(4):331-337.
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Objective. An increased prevalence of type 2 diabetes mellitus (DM) has been associated with HCV in the non-HIV infected populations. To describe a similar association among HIV subjects, and explore the biological mechanisms. Methods. In a cross-sectional analysis, we compared the prevalence of DM (using American Diabetes Association criteria) and insulin resistance (HOMA IR) and dyslipidemia among ARV naïve patients with HIV and HIV/HCV infected patients enrolled in CPCRA FIRST (058) and the Metabolic Substudy (061). Results. Among 1389 enrolled in the FIRST study and had HCV serology, the prevalence of diabetes was higher (5.9%) among HCV/HIV as compared to 3.3% among those with HIV alone (p=0.04). Among 417 enrolled in the metabolic substudy, 88 (21%) had HIV/HCV co-infection. As in the main study, the prevalence of DM was higher in HIV/HCV group (9 vs. 3%, p=0.03). The HIV/HCV infected were significantly older (43 vs. 37 years), non-white (83 vs. 70%), with a history of IDU (55 vs. 3%), had higher AST (61 vs. 39 U/l), ALT (55 vs. 43 U/l,) and lower cholesterol levels (3.97 vs. 4.25 mmol/l). By multivariate analysis among subjects <50 years, association between HCV and diabetes remained significant after adjusting for BMI, family history of diabetes (OR=3.7, 95% CI: 1.3–11.1, p=0.02). The insulin resistance (HOMA IR) was not different between the two groups, however, the prevalence of dyslipidemia was lower among HCV co-infected subjects. Conclusions. Subjects with HIV/HCV co-infection have a higher prevalence of diabetes and thus may need to be screened for it prior to initiation of anti-retroviral therapy, particularly if it is a PI based regimen.
Tedaldi E, Huppler Hullsiek K, Malvestutto C, Arduino R, Fisher E, Gaglio P, Jenny-Avital E, McGowan J, Perez G. Prevalence and characteristics of HCV coinfection in an HIV clinical trials group. Clin Infect Dis 2003 May 15;36(10):1313-7. Epub 2003 May 06.
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The baseline prevalence of hepatitis C virus (HCV) and human immunodeficiency virus (HIV) coinfection among 2705 patients enrolled in HIV clinical trials in the Community Programs for Clinical Research on AIDS (CPCRA) was 16.6%. For men, multivariate logistic regression showed that the baseline prevalence of HIV- HCV coinfection was positively associated with history of injection drug use, older age, antiretroviral therapy naive status, African American or Latino ethnicity, and no history of having sex with men. No association was found with baseline CD4+ cell count or HIV RNA level. The prevalence of HCV coinfection in a diverse HIV clinical trials cohort provides additional information about risk behaviors and demographic factors that can be used in the analysis of clinical and virologic outcomes.
Shlay JC, El-Sadr WM, Bartsch G, Wang J, Gibert C, Carr A, Raghavan SS. A simple questionnaire to assess alterations in body appearance in HIV-infected patients. Int J Body Composition Research 2004;1(2):81-90.
This article is available as a PDF File
This questionnaire was developed in order to assess perception of any changes in body appearance and to determine its potential use in a large diverse cohort of antiretroviral naive HIV-infected patients. For this study, HIV-infected patients (n=227) enrolling into a metabolic study completed a ten-item questionnaire on alterations in body appearance and had body mass index (BMI) and antrhropometric measurements performed. The questionnaire assessed subjective changes in body appearance over the past four months (thinning, no change, increase in sizes). Concordance of survey results with mean body circumference (arm, waist, hip, thigh), mean skinfold thickness (triceps, suprascapular, subscapular, abdomen, thigh) and the BMI were evaluated. At baseline, over a third of participants reported no changes for all six sites (i.e., face, arms, breast, waist, buttocks, thighs); however, of those reporting any changes for all six sites, thinning was more common (7.9%) than was an increase in sizes (0.4%). For the body circumference, perceived changes of face, breast, waist, buttocks, and thighs were positively correlated with the mean values for all measure body circumferences (P <0.18). For the skinfolds, changes in face, buttocks, waist and thighs were positively correlated with all five skinfold thickness measurements (P <0.05); arms and breast were positively correlated with all measurements except suprascapular (arms: P=0.06), abdomen (arms; P=0.13, breast: P=0.12) and triceps (breast: P=0.21). For face, arms, waist, buttocks and thighs, self-reported body perception was correlated with mean BMI (P < 0.05). In conclusion, responses from the survey correlated well with body circumference and skinfold measurements, supporting the potential use of this simple questionnaire in antiretroviral naïve adults.
Reisler RB, Han C, Burman WJ, Tedaldi EM, Neaton JD. Grade 4 events are as important as AIDS events in the era of HAART. J Acquir Immune Defic Syndr 2003;34:379-386.
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Objective: To estimate incidence and predictors of serious or life-threatening events that are not AIDS defining, AIDS events, and death among patients treated with highly active antiretroviral therapy (HAART) in the setting of 5 large multicenter randomized treatment trials conducted in the United States.
Methods: Data were analyzed from 2947 patients enrolled from December 1996 through December 2001. All patients were to receive antiretrovirals throughout follow-up. Data collection was uniform for all main outcome measures: serious of life-threatening (grade 4) events, AIDS, and death.
Results: During follow-up, 675 patients experienced a grade 4 event (11.4 per 100 person-years); 332 developed an AIDS event (5.6 per 100 person-years); and 272 died (4.6 per 100 person-years). The most common grade 4 events were liver related (148 patients, 2.6 per 100 person-years). Cardiovascular events were associated with the greatest risk of death (hazard ratio = 8/64; 95% CI: 5.1 to 14.5). The first grade 4 event and the first AIDS event were associated with similar risks of death, 5.68 and 6.95, respectively.
Conclusions: Grade 4 events are as important as AIDS events in the era of HAART. To adequately evaluate the impact of HAART on morbidity, comorbidities and other key factors must be carefully assessed.
Mannheimer S, Friedland G, Matts J, Child C, Chesney M. The consistency of adherence to antiretroviral therapy predicts biologic outcomes for human immunodeficiency virus-infected persons in clinical trials.. Clin Infect Dis 2002; 34:1115-1121.
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We prospectively studied long-term antiretroviral adherence patterns and their impact on biologic outcomes for human immunodeficiency virus (HIV)-infected participants in 2 randomized, multicenter clinical trials. For the period from baseline to month 12 of the study, participants who reported adherence levels of 100%, 80%-99%, and 0%-79% had plasma HIV RNA levels that decreased by 2.77, 2.33, and 0.67 log10 copies/mL, respectively (P <.001), whereas their CD4 counts increased by 179, 159, and 53 cells/mm3, respectively (P <.001). Adherence predicted nondetectable HIV RNA levels (<50 copies/mL) at 12 months of follow-up (P <.01). The HIV RNA level was nondetectable on 72% of participants who reported 100% adherence at all 4 follow-up visits, compared with 66%, 41%, 35%, and 13% of participants who reported 100% adherence at 3, 2, 1, or 0 follow-up visits, respectively (P <.001). Onwhite race was associated with poorer adherence (P </001), and older age was associated with better adherence (P <.001).
Wheeler DA, Gibert CL, Launer CA, Muurahainen N, Elion RA, Abrams DI, et al.
Weight loss as a predictor of survival and disease progression in HIV infection. JAIDS 1998;18(1)80-85.
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Severe weight loss in HIV is associated with decreased survival. A loss of less than five percent of body weight over four months is associated with an increased risk of death and opportunistic complication in HIV. More than five percent weight loss is associated with an increased risk of individual opportunistic complications.
Saravolatz L, Neaton JD, Sacks L, Deyton L, Rhame F, Sherer R. CD4+ T lymphocyte counts and patterns of mortality among patients infected with the human immunodeficiency virus who were enrolled in the Community Programs for Clinical Research on AIDS. Clin Infect Dis 1996;22(3):513-520.
CD4+ T lymphocyte measurements are used frequently in clinical practice and have important prognostic implications. In each CD4+ cell stratum, mortality rates were higher for those with a history of disease progression at entry into the study; across all CD4+ cell strata, mortality was 60% greater. These data should be useful in planning clinical trials, and they have implications in terms of the frequency with which CD4+ cell counts should be measured to monitor the progression of HIV infection.
Chan ISF, Neaton JD, Saravolatz LD, Crane LR, Osterberger J. Frequencies of
opportunistic diseases prior to death among HIV infected persons. AIDS 1995;9:1145-1151.
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The investigators report on the results of a descriptive case series study, designed to provide a history of opportunistic events experience by 1,205 HIV-infected CPCRA patients before their deaths and to determine whether the frequency of events varies according to demographic characteristics, risk behaviors, or geographic location. PCP, MAC, CMV, wasting syndrome, invasive candidiasis, and bacterial pneumonia are the most common opportunistic AIDS-defining events experienced by these patients prior to death. Continued research on the etiology and prevention of these diseases should be a high priority.
Melnick SL, Sherer R, Louis TA, Hillman D, Rodriguez EM, Lackman C, et al. Survival
and disease progression according to gender of patients with HIV infection. JAMA 1994;272(24):1915-1921.
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This multicenter cohort study was designed to compare disease progression and mortality between women (n=768) and men (n=3779) infected with HIV, while controlling for differences in baseline predictors of disease progression. The study showed that women were at higher risk for death and bacterial pneumonia than men but that risk for disease progression was not significantly different between genders. The survival difference might be attributed to differential access to or utilization of health care resources, including antiretroviral therapy and PCP prophylaxes. Other reasons for lower survival in women might include differences in HIV-infected men and women with respect to socioeconomic status, homelessness, domestic violence, substance abuse, and degree of social support.
The authors identified the relative impact of diverse social factors on survival as an area which requires further study. They also mentioned the importance of accurate information on causes of death in this type of research and discuss the limitations of their data on causes of death.
An important clinical finding regarding the natural history of HIV infection was the lack of a difference in the incidence of, and morbidity and mortality from, HIV-related conditions, including the common AIDS-defining opportunistic infections and malignancies. The implication for clinicians who care for HIV-infected women is that treatment choices, drug dosages, and clinical outcomes from studies conducted exclusively or primarily on men may reasonably be applied to the care of HIV-infected women. At the same time, clinicians need to be more attentive to features of HIV infection in women which may be associated with increased mortality and morbidity in women, such as domestic violence and chemical dependency.
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