A Study Comparing Safety Of Abacavir And Lamivudine Administered Once-Daily As A Single Tablet Versus The Same Drugs Administered Twice-Daily As Separate Tablets (ALOHA Study)

• Status: Completed
• Trial end date: 2005-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study was designed to evaluate if subjects who took 600 mg of abacavir and 300 mg of lamivudine once-daily as a single tablet were just as likely to have adverse events compared to subjects who took 300 mg of abacavir and 150 mg of lamivudine administered as separate tablets twice-daily.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Abacavir; Lamivudine

Criteria

Inclusion Criteria:

• Have HIV-1 infection.

• Had not received any prior HIV treatment for more than 14 days.

• At least 1000 copies of HIV-1 RNA.

• Willing to provide signed informed consent.

Exclusion Criteria:

• Enrolled in other investigational drug studies.

• Female subjects who are pregnant or breastfeeding.

• History of allergy or hypersensitivity to abacavir or lamivudine.

• Certain medical conditions that would make subjects ineligible.