NCT00044577

New Tablet Containing Two FDA Approved Anti-HIV Drugs For Antiretroviral Therapy Experienced HIV-1 Infected Subjects

See Detailed Description

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 166 (planned)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A 48-week study to investigate the safety and effectiveness of a new compact formulation of two already FDA-approved anti-HIV drugs in subjects who have already been receiving treatment for their HIV infection.

Detailed description

A phase III, randomized, open-label, parallel, multicenter study to evaluate treatment with fixed-dose combination of abacavir/lamivudine (600mg/300mg) once-daily versus abacavir (300mg) twice-daily and lamivudine (300mg) once-daily in combination with tenofovir once-daily and a new PI or NNRTI for 48 weeks in ART-experienced HIV-1 infected patients.

Conditions

• Infection, Human Immunodeficiency Virus I
• HIV Infection

Interventions

Type	Name	Description
DRUG	abacavir/lamivudine
DRUG	abacavir
DRUG	lamivudine
DRUG	tenofovir

Timeline

• Start date: 2002-07-16
• Primary completion: 2004-05-25
• Completion: 2004-05-25
• First posted: 2002-09-04
• Last updated: 2020-03-24

Locations

76 sites across 9 countries: United States, Belgium, Canada, France, Germany, Italy, Portugal, Spain, United Kingdom