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

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00000940

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

121

Starts

1999-05-01

Expected to finish

2006-10-01

Last updated by the study team

2021-10-29

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• USC CRS — Los Angeles, California, United States
• UCLA CARE Center CRS — Los Angeles, California, United States
• Ucsd, Avrc Crs — San Diego, California, United States
• Ucsf Aids Crs — San Francisco, California, United States
• University of Colorado Hospital CRS — Aurora, Colorado, United States
• Univ. of Hawaii at Manoa, Leahi Hosp. — Honolulu, Hawaii, United States
• Massachusetts General Hospital ACTG CRS — Boston, Massachusetts, United States
• SSTAR, Family Healthcare Ctr. — Fall River, Massachusetts, United States
• Washington U CRS — St Louis, Missouri, United States
• Beth Israel Med. Ctr. ACTU — New York, New York, United States
• NY Univ. HIV/AIDS CRS — New York, New York, United States
• Columbia P&S CRS — New York, New York, United States
• AIDS Care CRS — Rochester, New York, United States
• McCree McCuller Wellness Ctr. at the Connection, Infectious Disease Unit — Rochester, New York, United States
• Univ. of Rochester ACTG CRS — Rochester, New York, United States
• Unc Aids Crs — Chapel Hill, North Carolina, United States
• Hosp. of the Univ. of Pennsylvania CRS — Philadelphia, Pennsylvania, United States
• The Miriam Hosp. ACTG CRS — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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