Phase 4 N=200 Randomized Treatment

Study of Reyataz in HIV-infected Patients With Lipodystrophy Syndrome

HIV-Associated Lipodystrophy Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT00135356 ↗

Enrolled (actual)

200

Serious AEs

8.0%

Results posted

May 2010

Primary outcome: Primary: Change From Baseline in Trunk-to-limb Fat Ratio as Measured by Dual Energy X-Ray Absortiometry (DEXA) at Week 48 — 0.02; -0.02; 0.02; -0.01 ratio — p=0.48

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Atazanavir (ATV) + ritonavir (RTV), continuation of backbone 2 nucleoside reverse transcriptase inhibitor (NRTIs) (Drug); continuation of current HAART (boosted protease inhibitor [PI] combination + 2 NRTIs) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bristol-Myers Squibb
Primary completion: Jul 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Trunk-to-limb Fat Ratio as Measured by Dual Energy X-Ray Absortiometry (DEXA) at Week 48	0.02; -0.02; 0.02; -0.01	0.48
SECONDARY Change From Baseline in Trunk-to-limb Fat Ratio as Measured by DEXA at Week 96	0.04; 0.02; 0.04; 0.05	0.73
SECONDARY Mean Percent Change From Baseline in Visceral Adipose Tissue (VAT) Area by Computed Tomography (CT) Scans and in Trunk Fat by DEXA.	6.5; -0.4; 4.3; 2.1; 2.6; -1.8	0.27
SECONDARY Mean Percent Change From Baseline in Peripheral Adipose Tissue (Limb Fat) by DEXA and by Changes in Subcutaneous Adipose Tissue (SAT) Area by CT Scans	-2.2; -5.9; -3.5; -9.7; 0.9; -3.6	0.16
SECONDARY Mean Percent Change From Baseline in Total Body Fat by DEXA and in Total Adipose Tissue (TAT) Area by CT Scans	0.0; -3.5; -0.9; -5.0; 1.9; -3.7	0.19
SECONDARY Mean Percent Changes From Baseline in Fasting Lipids	-13.0; -1.0; -6.2; -2.6; -14.8; -0.6	—
SECONDARY Mean Changes From Baseline in Fasting Glucose at Week 48 and Week 96	3.6; -3.3; 1.2; 3.0	—
SECONDARY Mean Changes From Baseline in Fasting Insulin at Week 48 and Week 96	14.1; 21.8; 1.3; -4.1; 0.0; 0.3	—
SECONDARY Mean Changes From Baseline in Fasting Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)	3.42; 5.43; 0.74; -1.73; 0.28; 1.00	—
SECONDARY Mean Changes From Baseline in Body Weight at Week 48 and Week 96	1; -1; 0; -1	—
SECONDARY Mean Changes From Baseline in Waist Circumference at Week 48 and Week 96	-1; -1; -1; -1	—
SECONDARY Mean Changes From Baseline in Body Mass Index at Week 48 and Week 96	0.3; -0.2; 0.2; -0.5	—
SECONDARY Mean Changes From Baseline in Waist-to-Hip Ratio at Week 48 and Week 96	-0.01; -0.01; -0.01; -0.01	—
SECONDARY Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation	0; 0; 8; 7; 5; 3	—
SECONDARY Percentage of Participants With Abnormal Liver Function Tests	34; 23; 1; 0; 0; 0	—
SECONDARY Percentage of Participants With Adverse Events (AEs) Leading to Discontinuation	5; 3; 2; 0; 1; 0	—
SECONDARY Kaplan-Meier Cumulative Proportion of Participants Without Virologic Rebound (HIV RNA ≥400 c/mL) at Timepoints up to Week 96 in Treated Participants With HIV RNA <400 c/mL at Baseline	0.9837; 1.000; 0.9837; 1.000; 0.9753; 0.9841	—
SECONDARY Mean Change From Baseline in CD4 Count	14; 44; 3; 82	—

Summary

The purpose of this clinical research study is to learn if human immunodeficiency virus (HIV)-infected subjects with abdominal fat accumulation on their highly active antiretroviral treatment (HAART) regimen have better changes in fat distribution after switching to atazanavir-ritonavir than those remaining on their current protease inhibitor boosted HAART regimen.

Eligibility Criteria

Inclusion Criteria

HIV-1 infected on HAART regimen containing 2 NRTI and boosted PI for at least 12 weeks prior to screening. Subjects may not have experienced virological failure to more than one prior PI-containing regimen. Must be able to swallow tablets
Viral load 0.90 and Waist Circumference >88.2 cm for men and Waist Circumference >75.3 for women

Exclusion Criteria

Pregnant or breastfeeding women
New HIV-related opportunistic infections
Active alcohol or substance use
Grade 4 lab toxicity
History of taking atazanavir (ATV)
Prohibited therapies, including non-nucleoside reverse transcriptase inhibitors (NNRTI)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00135356). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.