At a glance
ClinicalIndex Comparison Record- ✓HIV-1 infection on HAART containing 2 NRTIs and boosted PI for ≥12 weeks before screening
- ✓Viral load <400 c/mL at screening and stable for ≥6 months
- ✓Evidence of fat redistribution with lipohypertrophy: waist-to-hip ratio >0.90 and waist circumference >88.2 cm (men) or >75.3 cm (women)
- ✓No virological failure to more than one prior PI-containing regimen
- ✕Pregnant or breastfeeding
- ✕New HIV-related opportunistic infections
- ✕Active alcohol or substance use
- ✕Grade 4 lab toxicity
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 4 clinical trial evaluating Atazanavir (ATV) + ritonavir (RTV), continuation of backbone 2 nucleoside reverse transcriptase inhibitor (NRTIs) and continuation of current HAART (boosted protease inhibitor [PI] combination + 2 NRTIs) for HIV-Associated Lipodystrophy Syndrome. Completed, enrolled 219 participants across 30 sites in 9 countries.
Detailed 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.
Study Details
Timeline
Interventions
Capsules, Oral, ATV 300 mg + RTV 100 mg once daily up to 96 weeks
Protease inhibitor \[PI\] combination + 2 NRTIs