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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: HIV Infections

Treatments: Drug: stavudine extended-release, lamivudine, efavirenz

Study type: Interventional

Funder types: Industry

Identifiers

NCT00135369

AI455-135

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)