Effect of the Atazanavir (ATV) 150L Mutation on Subsequent Treatment Response in HIV Infected Subjects

Completed

• Conditions: HIV Infection
• Interventions: Drug: LPV/RTV + 2NRTIs

• Registration Number: NCT00096746
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

This study will compare the response of subjects who failed a first-line ATV-containing regimen and who have the 150L-containing virus to subsequent protease inhibitor (PI)-containing therapy with that of a cohort who has failed a first-line reverse transcriptase inhibitor (NNRTI), and is subsequently receiving PI-containing therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2004-11-15
• Study First Submitted QC: 2004-11-15
• Study First Posted: 2004-11-16
• Primary Completion: 2006-09
• Study Completion: 2006-09
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-12
• Last Update Posted: 2011-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Currently on a first-line antiretroviral regimen containing ATV with a confirmed rebound and a genotype that verifies the presence of an 150L mutation OR on a first-line regimen containing an NNRTI and PI-naive, with a confirmed rebound

Exclusion Criteria

• Women of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the study.
• Women who are pregnant or breastfeeding.
• A life expectancy of <12 months.
• Presence of a newly diagnosed HIV-related opportunistic infection or any other medical condition requiring acute therapy at the time of enrollment.
• Active alcohol or substance abuse sufficient, in the investigator's opinion, to prevent adequate adherence to study therapy or to increase the risk of developing pancreatitis or chemical hepatitis.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A1	LPV/RTV + 2NRTIs	HIV infected individuals on first line ATV based HAART with presence of I50L mutation.
A2	LPV/RTV + 2NRTIs	HIV infected PI naïve on failed NNRTI based regimen.

Primary Outcome Measures

Name	Time	Method
The log10 HIV RNA change from baseline for each cohort.	through Week 48

Secondary Outcome Measures

Name	Time	Method
Evaluate proportion of patients with plasma HIV RNA <50 copies/mL	at Weeks 24, 48, 72, and 96.

Trial Locations

Locations (2)

Local Institution; 🇿🇦 Rugby, Western Cape, South Africa

Local Instution; 🇺🇸 Lexington, Kentucky, United States