NCT00002233

A Study of a Combination of Four Drugs in Patients With Recent HIV Infection

A Phase II, 48-Week, Uncontrolled, Open-Label Study Designed to Evaluate the Safety and Efficacy of Quadruple Antiretroviral Therapy (EPIVIR, Abacavir, Amprenavir, and Indinavir) in Subjects Acutely Infected With HIV-1

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (planned)
• Sponsor: Glaxo Wellcome · Industry
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see if it is safe to give a combination of four anti-HIV drugs to patients recently infected with HIV who have never received anti-HIV treatment. The effects of this combination of drugs on the immune system and the level of HIV in the body are studied also. The four-drug combination includes lamivudine, abacavir, amprenavir, and indinavir.

Detailed description

Patients receive a four-drug regimen consisting of two nucleoside reverse transcriptase inhibitors (3TC and abacavir) and two protease inhibitors (amprenavir and indinavir) for a minimum of 48 weeks. At specified time points, patients undergo physical assessments and efficacy evaluations which include plasma HIV-1 RNA measurements and CD4 cell counts. Depending on the immunologic and virologic status of the patient, further testing may be done to determine whether quadruple drug therapy can attain undetectable viral levels.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Indinavir sulfate
DRUG	Abacavir sulfate
DRUG	Amprenavir
DRUG	Lamivudine

Timeline

• First posted: 2001-08-31
• Last updated: 2005-06-24

Locations

2 sites across 1 country: United States