NCT00046176

A HIV Study Of A Fixed-Dose Combination Tablet In Antiretroviral Experienced Patients

A Phase III, 48-Week, Open-Label, Randomized, Multicenter Study of the Safety and Efficacy of the Abacavir/Lamivudine Fixed-Dose Combination Tablet Administered QD Versus Abacavir + Lamivudine Administered BID in Combination With a PI or NNRTI in Antiretroviral Experienced Patients.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (planned)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a 48-week study designed to evaluate the safety and efficacy of a fixed-dose combination tablet administered once-a-day versus the individual tablets administered twice-a-day within 3-drug combination regimens in ART (antiretroviral)-experienced HIV-1 infected patients.

Conditions

• Infection, Human Immunodeficiency Virus I
• HIV Infection

Interventions

Type	Name	Description
DRUG	abacavir/lamivudine
DRUG	abacavir
DRUG	lamivudine

Timeline

• Start date: 2002-08-26
• Primary completion: 2004-05-17
• Completion: 2004-05-17
• First posted: 2002-09-23
• Last updated: 2020-03-24

Locations

56 sites across 4 countries: United States, Costa Rica, Panama, Puerto Rico