HIV Infection
Conditions
Keywords
Treatment Experienced
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.
Interventions
DRUGLPV/RTV + 2NRTIs
Tablets, Oral, Variable, Twice daily, 48 weeks.
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The log10 HIV RNA change from baseline for each cohort. | through Week 48 |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate proportion of patients with plasma HIV RNA <50 copies/mL | at Weeks 24, 48, 72, and 96. |
Countries
Argentina, Brazil, Guatemala, Mexico, Peru, South Africa, United States
Outcome results
None listed