A Study on Amprenavir in Combination With Other Anti-HIV Drugs in HIV-Positive Patients

Completed · Phase 2

Conditions studied: HIV Infections

In brief

The purpose of this study is to compare 4 different combinations of anti-HIV drugs and to determine the number of people whose HIV blood levels decrease to 200 copies/ml or less while on the treatment. This study evaluates the safety of these drug combinations, which include an experimental protease inhibitor (PI), amprenavir. Despite the success that many patients have had with PI treatment regimens, there is still a possibility that patients receiving PIs may continue to have high HIV blood levels. Because of this possibility, alternative drug combinations containing PIs are being studied. It appears that amprenavir, when taken with 3 or 4 other anti-HIV drugs, may be effective in patients with prior PI treatment experience.

Key facts

Study ID

NCT00000912

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

475

Expected to finish

2000-05-01

Last updated by the study team

2021-10-29

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients may be eligible for this study if they:
• Are HIV-positive.
• Have current virologic failure (2 consecutive HIV blood levels above 1,000 copies/ml) while on PIs.
• Are over 13 years of age (consent of parent or guardian required if under 18).
• Agree to practice abstinence or use effective methods of birth control during the study and for 90 days after.

You may not qualify if…

• Patients will not be eligible for this study if they:
• Have hepatitis within 90 days prior to study entry.
• Have a history of a peripheral neuropathy within 60 days of study entry.
• Have an unexplained temperature for a 7-day period.
• Have chronic diarrhea within 30 days prior to study entry.
• Have cancer requiring chemotherapy.
• Received any therapy for infection or other illness within 30 days prior to study entry.
• Have received certain other medications.
• Are pregnant or breast-feeding.

Where it is running

• Univ of Southern California / LA County USC Med Ctr — Los Angeles, California, United States
• USC Univ Hosp & Ambulatory Hlth Care Ctr / USC Med Ctr — Los Angeles, California, United States
• UCLA CARE Ctr — Los Angeles, California, United States
• Willow Clinic — Menlo Park, California, United States
• Univ of California / San Diego Treatment Ctr — San Diego, California, United States
• San Francisco AIDS Clinic / San Francisco Gen Hosp — San Francisco, California, United States
• San Francisco Gen Hosp — San Francisco, California, United States
• Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium — San Jose, California, United States
• San Mateo AIDS Program / Stanford Univ — Stanford, California, United States
• Stanford Univ Med Ctr — Stanford, California, United States
• Univ of Colorado Health Sciences Ctr — Denver, Colorado, United States
• Howard Univ — Washington D.C., District of Columbia, United States
• Univ of Miami School of Medicine — Miami, Florida, United States
• Emory Univ — Atlanta, Georgia, United States
• Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr — Atlanta, Georgia, United States
• Queens Med Ctr — Honolulu, Hawaii, United States
• Univ of Hawaii — Honolulu, Hawaii, United States
• Tripler Army Med Ctr — Tripler AMC, Hawaii, United States
• Northwestern Univ Med School — Chicago, Illinois, United States
• Cook County Hosp — Chicago, Illinois, United States
• Rush Presbyterian - Saint Luke's Med Ctr — Chicago, Illinois, United States
• Charity Hosp / Tulane Univ Med School — New Orleans, Louisiana, United States
• Tulane Univ School of Medicine — New Orleans, Louisiana, United States
• Johns Hopkins Hosp — Baltimore, Maryland, United States
• Harvard (Massachusetts Gen Hosp) — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.