Drug Interactions of Amprenavir and Efavirenz, in Combination With a Second Protease Inhibitor, in HIV-Negative Volunteers

• Status: Completed
• Trial end date: 2004-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to measure the blood levels of amprenavir (APV) alone, APV combined with efavirenz (EFV), and APV/EFV combined with a third drug (nelfinavir [NFV], indinavir [IDV], ritonavir soft gel capsules [RTV sgc], or saquinavir soft gel capsules [SQV sgc]).

Anti-HIV therapy with 3 or 4 drugs is currently the recommended approach for treating HIV infections. Doctors need to know the best dosages of certain drugs when they are given in combination. This study will measure the blood levels of APV alone, APV combined with EFV, and APV/EFV plus a second PI in healthy volunteers. It will study the safety and tolerance of these drugs.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Amprenavir; Efavirenz; HIV Protease Inhibitors; Indinavir; Nelfinavir; Protease Inhibitors; Ritonavir; Saquinavir

Criteria

Inclusion Criteria

Volunteers may be eligible for this trial if they:

• Are HIV negative.

• Are 18 to 65 years old.

• Agree to practice birth control and not donate sperm while on the study and for 3 months after, if a man. (This study has been changed. Male volunteers are now prohibited from donating sperm.)

• Have a stable weight during the past 6 months of at least 110 pounds and are close to ideal body weight.

Exclusion Criteria

Volunteers will not be eligible for this trial if they:

• Are women able to have children.

• Have heart or blood disease, kidney disease, stomach or intestinal problems, conditions affecting the nervous system, hormonal problems, any immune system problems, lung disease, or mental conditions, including the following: high blood pressure, heart disease, diabetes, asthma, elevated cholesterol, elevated triglycerides, inflamed pancreas, and blood-clotting disorders requiring anticoagulation.

• Have any stomach or intestinal problem that may interfere with the ability to take drugs

• Have any other medical condition that may interfere with being part of the study.

• Have been diagnosed with serious mental disorders such as depression, bipolar affective disorder, schizophrenia, or attempted suicide. Patients who have had less serious mental conditions that have been resolved may be included in the study, with approval.

• Have received protease inhibitors, nonnucleoside reverse transcriptase inhibitors, or experimental agents (not approved by the FDA for the use for which it is being tested) within 60 days of study entry.

• Have received treatment for an infection or other medical illness within 14 days of study entry.

• Have had high unexplained fever, or an illness with high fever lasting 3 or more days within 14 days of study entry.

• Have a history of allergies to any of the study drugs or their components, such as gelatin.

• Have used prescribed medications within 14 days of study entry.

• Have used natural or homeopathic remedies including herbal teas within 14 days of entering the study.

• Are unable to follow the schedule for study drugs during the trial.

• Are unable to participate in the blood level studies.

• Actively abuse drugs or alcohol.

• Change existing tobacco smoking habits during the study.

• Cannot avoid strenuous exercise or constant activity for the study period.

• Cannot avoid taking caffeine or alcohol at certain times before the blood level studies.

• Have had an allergic reaction to any drugs.

• (This protocol has been changed. Entry criteria are different from the original.)