Five-Drug Anti-HIV Treatment Followed by Treatment Interruption in Patients Who Have Recently Been Infected With HIV

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will determine what effect taking a combination of five anti-HIV drugs during the early stage of HIV infection, then temporarily stopping them once or twice, may have on the amount of HIV virus in the blood (viral load). The study will also evaluate the safety and effectiveness of this anti-HIV drug combination.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Abacavir; Amprenavir; Dideoxynucleosides; Lamivudine; Ritonavir; Stavudine

Criteria

Inclusion Criteria:

• Acute HIV infection (recently infected with HIV or recent seroconversion)

• Karnofsky status of 80 or greater within 14 days prior to study entry

• Acceptable methods of contraception

• Able and willing to give written informed consent

Exclusion Criteria:

• Previously received anti-HIV drugs

• Hepatitis within 30 days prior to study entry

• Pancreatitis within 120 days prior to study entry

• Radiation or chemotherapy within 30 days prior to study entry

• Certain medications within 14 days prior to study entry

• Experimental or investigational therapy within 30 days prior to study entry

• Illness (non-HIV infection, cancer, etc.) at the time of study entry

• Pregnant or breastfeeding