A Study to Compare Two Anti-HIV Drug Combinations

Roche

Status and phase: Completed; Phase 3

Conditions: HIV Infections

Treatments: Drug: Saquinavir; Drug: Efavirenz; Drug: Ritonavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002447

NR15720C/M61027

229R

Details and patient eligibility

About

The purpose of this study is to compare 2 anti-HIV drug combinations.

Full description

Patients are stratified by HIV RNA: 5,000-75,000 vs greater than 75,000 copies/ml by Amplicor assay. Patients are randomized to two arms. Arm A receives SQV plus RTV plus two NRTIs. Arm B receives EFV plus two NRTIs. Patients must take their dose at approximately the same time every day. Patients have the option of taking daily dose in AM or PM. Patients are evaluated for changes in plasma HIV RNA levels and CD4/CD8 counts and for adverse experiences and laboratory determinations. Evaluations are made every 4-8 weeks until Week 48. Patients continuing beyond Week 48 who reach Weeks 60, 72, 84, and common study closure, will be seen at those weeks.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Patients may be eligible for this study if they:

• Are HIV-positive.
• Have a viral load of at least 5,000 copies/ml and a CD4 cell count of at least 75 cells/mm3.
• Are at least 18.
• Are able to complete the study.

Exclusion Criteria

Patients will not be eligible for this study if they:

• Have taken any anti-HIV medications for more than 2 weeks.
• Are pregnant or breast-feeding.