A Study of the Safety and Effectiveness of Combination Anti-HIV Therapy in HIV-Infected Adults

Phase 4

Completed

• Conditions: HIV Infections

• Registration Number: NCT00004585
• Lead Sponsor: Glaxo Wellcome

Brief Summary

The purpose of this study is to see if a certain combination of anti-HIV drugs is safe and effective in HIV-infected patients. The drug combination includes a tablet containing lamivudine and zidovudine (called Combivir) plus abacavir plus efavirenz.

Detailed Description

Patients take open-label Combivir plus abacavir plus efavirenz for 48 weeks. \[AS PER AMENDMENT 4/20/00: Patients taking Combivir plus abacavir at Week 24 receive the triple-nucleoside-combination tablet (TCT) (abacavir/lamivudine/zidovudine) beginning at Week 24 and continuing through Week 48, in combination with efavirenz (or nevirapine if the patient has made a protocol-allowed substitution). Patients not taking Combivir and abacavir at Week 24 will continue in the study on the substituted protocol-allowed drug regimen, provided their plasma HIV RNA is below 400 copies/ml at 24 weeks.\] Following enrollment on Study Day 1, on-study evaluations (virologic and safety) are performed at Weeks 2, 4, 8, 12, 16, and then every 8 weeks through Week 48 (end of study). CD4 evaluations are performed at baseline and at Weeks 4, 8, and then every 8 weeks through Week 48. Immune reconstitution testing is performed at baseline and at Weeks 12, 24, and 48. Patients complete the PMAQ7 version 1.1 medication adherence questionnaire at Weeks 2, 8, 12, 24, and 48 (or at their last study visit). All patients are requested to return for a post-study follow-up evaluation 2 to 4 weeks after the last on-study visit. Patients must have a plasma HIV RNA less than 400 copies/ml at Week 24 in order to continue in the study.

Study Timeline

• Study Start: 1999-10
• Study First Submitted: 2000-02-15
• Status Verified: 2000-11
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (5)

George Washington Univ Med Ctr; 🇺🇸 Washington, District of Columbia, United States

Tower Infectious Diseases / Med Associates Inc; 🇺🇸 Los Angeles, California, United States

North Shore Univ Hosp; 🇺🇸 Manhasset, New York, United States

Dallas Veterans Administration Med Ctr; 🇺🇸 Dallas, Texas, United States

Thomas Jefferson Univ; 🇺🇸 Philadelphia, Pennsylvania, United States