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

NCT00005762 | Completed

• 3 other identifiers: A504310671ACTG A5043
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

HIV Infections

Keywords

Drug Interactions; Drug Therapy, Combination; HIV Protease Inhibitors; Ritonavir; Dosage Forms; Saquinavir; VX 478; Anti-HIV Agents; Nelfinavir; Pharmacokinetics; efavirenz

Interventions

Indinavir sulfate DRUG

Ritonavir DRUG

Amprenavir DRUG

Nelfinavir mesylate DRUG

Efavirenz DRUG

Saquinavir DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (8)

Stanford CRS

Palo Alto, California, 943055107, United States

Location

University of Colorado Hospital CRS

Aurora, Colorado, 80262, United States

Location

Univ. of Hawaii at Manoa, Leahi Hosp.

Honolulu, Hawaii, 96816, United States

Location

Indiana Univ. School of Medicine, Infectious Disease Research Clinic

Indianapolis, Indiana, 462025250, United States

Location

Johns Hopkins Adult AIDS CRS

Baltimore, Maryland, United States

Location

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Vanderbilt Univ. Med. Ctr., AIDS Clinical Trials Ctr.

Nashville, Tennessee, 37203, United States

Location

University of Washington AIDS CRS

Seattle, Washington, 98104, United States

Location

Related Publications (1)

• Morse GD, Rosenkranz S, Para MF, Segal Y, Difrancesco R, Adams E, Brizz B, Yarasheski KE, Reichman RC. Amprenavir and efavirenz pharmacokinetics before and after the addition of nelfinavir, indinavir, ritonavir, or saquinavir in seronegative individuals. Antimicrob Agents Chemother. 2005 Aug;49(8):3373-81. doi: 10.1128/AAC.49.8.3373-3381.2005.

  PMID: 16048950 RESULT

MeSH Terms

Conditions

HIV Infections

Interventions

Indinavir; Ritonavir; amprenavir; Nelfinavir; efavirenz; Saquinavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Quinolines

Study Officials

• Gene Morse

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2000
• First Posted: August 31, 2001
• Study Start: March 1, 2001
• Study Completion: May 1, 2004
• Last Updated: November 1, 2021

Record last verified: 2021-10

Locations

US (8)