NCT00931801

BATAR: Individuals Currently Taking Boosted Atazanavir as Part of an HIV Treatment Regimen Will be Evaluated to See if Substituting Raltegravir for Nucleoside Transcriptase Inhibitors Will be Safe and Well Tolerated.

A Pilot Study of the Novel Antiretroviral Combination of Atazanavir and Raltegravir in HIV-1 Infected Subjects With Virologic Suppression on a Standard Regimen of Boosted Atazanavir, Tenofovir and Emtricitabine

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Community Research Initiative of New England · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this Phase IV pilot study is to evaluate the safety, tolerability, and satisfaction of a nucleoside analog reverse-transcriptase inhibitors (NRTI)sparing regimen for participants fully suppressed on an atazanavir/ritonavir based highly active antiretroviral therapy (HAART)regimen plus emtricitabine/tenofovir (Truvada). Several pharmacologic factors support this concept including the favorable drug interaction between atazanavir and raltegravir. Participants will be randomized to either continue on their current regimen or one of two study arms (atazanavir 300mg plus ritonavir 100mg daily plus raltegravir 400mg twice daily or atazanavir 300mg twice daily plus raltegravir 400mg twice daily). Participants will be followed for 48 weeks for safety, tolerability, and satisfaction. After baseline, the participants will have six clinic visits for evaluation and labs.

Conditions

• HIV

Interventions

Type	Name	Description
DRUG	atazanavir/raltegravir	Atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
DRUG	atazanavir/raltegravir	Atazanavir 300mg twice daily plus raltegravir 400mg twice daily
DRUG	atazanavir/tenofovir/emtricitabine	Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine

Timeline

• Start date: 2009-12-01
• Primary completion: 2012-02-01
• Completion: 2012-03-01
• First posted: 2009-07-02
• Last updated: 2017-07-21
• Results posted: 2013-03-11

Locations

9 sites across 1 country: United States