Study of Reyataz in HIV-infected Patients With Lipodystrophy Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00135356
• Date of registration: 25/08/2005
• Prospective Registration: No
• Primary sponsor: Bristol-Myers Squibb
• Public title: Study of Reyataz in HIV-infected Patients With Lipodystrophy Syndrome
• Scientific title: A Phase IV, Open-Label, Randomized, Multicenter Trial Assessing a Reyataz-Based Substitution Approach in the Management of Lipodystrophy Syndrome. Research Into Atazanavir in Lipodystrophy (The REAL Study)
• Date of first enrolment: July 2005
• Target sample size: 219
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00135356
• Study type: Interventional
• Phase: Phase 4

Countries of recruitment

Canada, France, Germany, Italy, Mexico, Netherlands, Poland, Spain, United Kingdom, United States

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion 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 <400 c/mL at screening and stable for at least 6 months

- Signs of fat redistribution and lipohypertrophy (abdominal) Waist to Hip Ratio >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)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

HIV-Associated Lipodystrophy Syndrome

Intervention(s)

Drug: continuation of current HAART (boosted protease inhibitor [PI] combination + 2 NRTIs)

Drug: Atazanavir (ATV) + ritonavir (RTV), continuation of backbone 2 nucleoside reverse transcriptase inhibitor (NRTIs)

Primary Outcome(s)

Change From Baseline in Trunk-to-limb Fat Ratio as Measured by Dual Energy X-Ray Absortiometry (DEXA) at Week 48 [Time Frame: Baseline, Week 48]

Secondary Outcome(s)

Mean Change From Baseline in CD4 Count [Time Frame: Baseline, Week 48, Week 96]

Mean Changes From Baseline in Fasting Glucose at Week 48 and Week 96 [Time Frame: Baseline, Week 48, Week 96]

Mean Changes From Baseline in Waist Circumference at Week 48 and Week 96 [Time Frame: Baseline, Week 48, Week 96]

Mean Percent Change From Baseline in Visceral Adipose Tissue (VAT) Area by Computed Tomography (CT) Scans and in Trunk Fat by DEXA. [Time Frame: Baseline, Week 48, Week 96]

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 [Time Frame: Weeks 8-12, Weeks 20-24, Weeks 32-36, Weeks 44-48, Weeks 56-60, Weeks 68-72, Weeks 80-84, Weeks 92-96]

Mean Changes From Baseline in Body Mass Index at Week 48 and Week 96 [Time Frame: Baseline, Week 48, Week 96]

Mean Percent Change From Baseline in Total Body Fat by DEXA and in Total Adipose Tissue (TAT) Area by CT Scans [Time Frame: Baseline, Week 48, Week 96]

Percentage of Participants With Abnormal Liver Function Tests [Time Frame: Week 48, Week 96]

Change From Baseline in Trunk-to-limb Fat Ratio as Measured by DEXA at Week 96 [Time Frame: Baseline, Week 96]

Mean Changes From Baseline in Body Weight at Week 48 and Week 96 [Time Frame: Baseline, Week 48, Week 96]

Mean Changes From Baseline in Fasting Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) [Time Frame: Baseline, Week 48, Week 96]

Percentage of Participants With Adverse Events (AEs) Leading to Discontinuation [Time Frame: Through Week 96]

Mean Changes From Baseline in Waist-to-Hip Ratio at Week 48 and Week 96 [Time Frame: Baseline, Week 48, Week 96]

Mean Percent Changes From Baseline in Fasting Lipids [Time Frame: Baseline, Week 48, Week 96]

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 [Time Frame: Baseline, Week 48, Week 96]

Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation [Time Frame: Through Week 96 of study therapy]

Mean Changes From Baseline in Fasting Insulin at Week 48 and Week 96 [Time Frame: Baseline, Week 48, Week 96]

Secondary ID(s)

AI424-131

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 07/05/2010
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00135356