Switching HIV-1 Infected Subjects From a Highly Active Anti-Retroviral Treatment (HAART) Regimen Dosed Twice Daily or More Frequently to a Once-Daily Regimen
Phase 3
Completed
- Conditions
- HIV Infections
- Registration Number
- NCT00135369
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to demonstrate that virologically controlled HIV-infected individuals can successfully switch from a standard-of-care regimen dosed twice-daily or more frequently to a simpler once-daily (QD) regimen while maintaining virologic control, as evaluated by the proportion of subjects who continue to have plasma HIV-1 levels \<50 copies/mL after switching to a QD regimen.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
- Documented HIV infection
- 18 years of age or older and weigh at least 40 kg
- Two plasma HIV RNA levels below the limit of quantification (one at least 90 days prior to the screening visit and one within 30 days of the patients baseline visit)
- Currently receiving a standard-of-care HAART regimen with at least one agent being dosed twice-daily or more frequently
Exclusion Criteria
- Pregnancy, breastfeeding or plans to become pregnant during the study period
- Any prior documented virologic failure to one or more HAART regimens
- Active AIDS-defining opportunistic infection or disease
- Proven or suspected acute hepatitis within 30 days prior to study entry
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Efficacy at week 48
- Secondary Outcome Measures
Name Time Method Safety, tolerability and efficacy at weeks (wks) 24 and 48; Effect on lipids at wks 24 and 48; Adherence, quality of life changes, treatment satisfaction and preference at wks 12, 24 and 48
Trial Locations
- Locations (1)
Local Institution
🇵🇷San Juan, Puerto Rico