The Rationale and Design of the CPCRA (Terry Beirn Community Programs for Clinical Research on AIDS) 058 FIRST (Flexible Initial Retrovirus Suppressive Therapies) Trial

MacArthur, Rodger D.; Chen, Li; Mayers, Douglas L.; Besch, C. Lynn; Novak, Richard M.; Berg-Wolf, Mary van den; Yurik, Teresa Mc Cabe; Peng, Grace; Schmetter, Barry; Brizz, Barbara; Abrams, Donald I.

doi:10.1016/s0197-2456(01)00111-8

Cited by 28 publications

(12 citation statements)

References 10 publications

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“…The data for this paper came from the Metabolic Study,15 a substudy of a long-term randomized clinical trial, Flexible Initial Retrovirus Suppressive Therapies (FIRST) 16 conducted by the Community Programs for Clinical Research on AIDS (CPCRA) 17…”

Section: Methodsmentioning

confidence: 99%

The Effect of Individual Antiretroviral Drugs on Body Composition in HIV-Infected Persons Initiating Highly Active Antiretroviral Therapy

Shlay

Sharma²,

Peng

et al. 2009

JAIDS Journal of Acquired Immune Deficiency Syndromes

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Objectives To examine the long-term effects of individual antiretroviral drugs on body composition among 416 persons initiating antiretroviral therapy (ART). Methods In a substudy of a clinical trial of persons initiating ART, changes in body composition attributable to individual ART were examined. ART assessed were: indinavir, ritonavir, nelfinavir, efavirenz, nevirapine, stavudine (d4T), zidovudine (ZDV), lamivudine (3TC), didanosine (ddI), and abacavir (ABC). Skinfolds and circumferences were measured at baseline and every 4 months. Mid-arm, mid-thigh and waist subcutaneous tissue areas (STAs) and non-subcutaneous tissue areas (NSTAs) were calculated. Rates of change per year of exposure to each individual ART drug were determined using multivariate longitudinal regression. Results D4T and ZDV use were associated with losses in STA and skinfold thickness. 3TC use was associated with gains in all STAs and skinfold thickness, while ABC use was associated with an increase in waist STA. Indinavir was associated with gains in waist STA, while indinavir, efavirenz and nevirapine were associated with increases in upper back skinfolds. D4T use was also associated with increases in all NSTAs; 3TC use was associated with the greatest increase in waist NSTA. Conclusions In this prospective non-randomized evaluation, the NRTIs d4T and ZDV were associated with decreases in STAs, while 3TC use was associated with increased STAs and waist NSTA.

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Section: Methodsmentioning

confidence: 99%

The Effect of Individual Antiretroviral Drugs on Body Composition in HIV-Infected Persons Initiating Highly Active Antiretroviral Therapy

Shlay

Sharma²,

Peng

et al. 2009

JAIDS Journal of Acquired Immune Deficiency Syndromes

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“…This analysis included participants in Community Programs for Clinical Research on AIDS (CPCRA) 058 (Flexible Initial Retrovirus Suppressive Therapies [FIRST]), a multicenter, randomized clinical trial conducted at 18 US sites that is managed by the National Institutes of Health-sponsored CPCRA [15]. During the period February 1999 through January 2002, antiretroviral-naive participants were randomized to 1 of 3 initial ART strategy groups: (1) the protease inhibitor (PI) strategy group, who received PI(s) plus nucleoside analogues;…”

Section: Symptoms and Quality Of Life Were Assessed Among Human Immunmentioning

confidence: 99%

Mild-to-Moderate Symptoms during the First Year of Antiretroviral Therapy Worsen Quality of Life in HIV-Infected Individuals

Mannheimer

Wold

Gardner

et al. 2008

Clinical Infectious Diseases

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Symptoms and quality of life were assessed among human immunodeficiency virus (HIV)-infected individuals initiating their first course of antiretroviral therapy. Symptoms, which were mostly mild or moderate, were common in the first year and significantly affected the patients' quality of life. Quality of life was inversely related to the number of symptoms and in the change in the number of symptoms from baseline.

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“…From 1999 through 2002 participants were randomly allocated (1:1:1) to one of three initial strategies: the protease inhibitor (PI) strategy (PI[s] + nucleoside reverse transcriptase inhibitors [NRTIs]); the non-nucleoside reverse transcriptase inhibitor (NNRTI) strategy (an NNRTI + NRTIs); or the 3-class strategy (PI[s] + an NNRTI + NRTI[s]). Clinicians could choose individual medications within the assigned strategy or those medications were randomly assigned for participants enrolled in class-specific substudies (14% of participants) [9]. This analysis was limited to the PI and NNRTI strategies in order to evaluate initial regimens that are similar to those currently recommended.…”

Section: Methodsmentioning

confidence: 99%

Antiretroviral medication adherence and class-specific resistance in a large prospective clinical trial

Gardner¹,

Hullsiek²,

Telzak³

et al. 2010

Aids

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Objective To assess the association between adherence to antiretroviral therapy and the presence of class-specific antiretroviral medication resistance. Design Secondary analysis of prospective clinical trial data Methods Participants randomized to the protease inhibitor (PI) or non-nucleoside reverse transcriptase inhibitor (NNRTI) strategies of the Community Programs for Clinical Research on AIDS (CPCRA) Flexible Initial Retrovirus Suppressive Therapies (FIRST) Study were included. Adherence was measured by 7-day self-report. Virological failure was defined as an HIV-RNA > 1000 at or after 4 months. The association between cumulative adherence and the development of class-specific genotypic resistance was assessed by Cox regression analysis. Results Included were 457 and 446 antiretroviral naïve participants on the PI and NNRTI strategies respectively. The median time to initial virological failure in the PI strategy was 1.2 years; 135 (30%) individuals failed with resistance. The median time to initial virological failure in the NNRTI strategy was 3.0 years; 127 (28%) failed with resistance. No association was found between cumulative adherence and PI resistance (HR 1.1, 95% CI 0.9 – 1.4 per 10% lower adherence). However, lower cumulative adherence was associated with an increased risk of NNRTI resistance at initial virological failure (HR 1.2, 95% CI 1.1 – 1.3 per 10% lower adherence). In both strategies lower cumulative adherence was associated with an increased risk of nucleoside reverse transcriptase inhibitor (NRTI) resistance at initial virological failure. Conclusions Adherence-resistance relationships are class-specific. For NRTIs and NNRTIs, initial virological failure with resistance is more likely at lower levels of cumulative adherence.

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The Rationale and Design of the CPCRA (Terry Beirn Community Programs for Clinical Research on AIDS) 058 FIRST (Flexible Initial Retrovirus Suppressive Therapies) Trial

Cited by 28 publications

References 10 publications

The Effect of Individual Antiretroviral Drugs on Body Composition in HIV-Infected Persons Initiating Highly Active Antiretroviral Therapy

The Effect of Individual Antiretroviral Drugs on Body Composition in HIV-Infected Persons Initiating Highly Active Antiretroviral Therapy

Mild-to-Moderate Symptoms during the First Year of Antiretroviral Therapy Worsen Quality of Life in HIV-Infected Individuals

Antiretroviral medication adherence and class-specific resistance in a large prospective clinical trial

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