NCT01194856

Switching From Efavirenz to Atazanavir/ Ritonavir in HIV-infected Subjects With Good Virologic Suppression

A Randomized Study to Evaluate the Effect of Switching From Efavirenz to Atazanavir/ Ritonavir on Lipoatrophy and Mitochondrial Dysfunction in HIV-infected Subjects With Good Virologic Suppression

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purposes of this study are to evaluate if switching an antiretroviral medication from efavirenz (EFV) to atazanavir/ ritonavir (ARV/r) will, in a 96-week period, change: 1. the amount of fat in HIV patients with lipoatrophy, 2. metabolic lab values such as your lipid (fat) profile, glucose (blood sugar), and insulin (a hormone that regulates glucose) in HIV patients with lipoatrophy.

Detailed description

Our study will evaluate the effects on peripheral fat of switching from EFV to ATV/r over 96 weeks in HIV+ patients with clinical lipoatrophy. From a virologic standpoint, EFV and ATV/r are medications which are recommended equally as preferred components of antiretroviral regimens in the December 2009 version of the Guidelines for the Use of Antiretroviral Agents in HIV-1 Infected Adults and Adolescents.\[20\] The study subjects should be receiving a stable EFV-containing antiretroviral (ART) regimen for at least 48 weeks prior to study entry. Blood will be saved for further investigations if needed. Safety parameters will be regularly assessed throughout the study. In addition, a subcutaneous fat biopsy will be obtained to measure fat mtDNA, mtRNA, and fat apoptosis. These measurements would provide significant insight into the clinical changes which have been recently described.

Conditions

• HIV Infection
• Mitochondrial Dysfunction

Interventions

Type	Name	Description
DRUG	Atazanavir/ritonavir	300 mg orally once daily with Ritonavir 100mg orally once daily for 96 weeks
DRUG	Efavirenz	Maintain dosage - 600 mg orally QHS for 96 weeks

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2010-09-03
• Last updated: 2017-08-11
• Results posted: 2017-08-11

Locations

1 site across 1 country: United States