A Study on Possible Interactions Between Protease Inhibitors (Anti-HIV Drugs) and Drugs Which Lower the Level of Fat in Your Blood

NCT00000941 | Completed Phase 1

• 3 other identifiers: A504710891ACTG A5047
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 13

Brief Summary

The purpose of this study is to find out whether taking protease inhibitors (anti-HIV drugs) together with lipid-lowering drugs (drugs which lower the amount of fat in the blood) has an effect on the level of drugs found in the blood compared to when these drugs are taken separately. The three protease inhibitors given in this study are ritonavir, saquinavir, and nelfinavir. The lipid-lowering drugs given are pravastatin, simvastatin, and atorvastatin. Anti-HIV drug therapy using protease inhibitors has become very common treatment for HIV-positive patients. Recently, however, serious side effects involving how the body uses fat have been reported in people taking protease inhibitors. Examples of these side effects are redistribution of body fat and development of diabetes. People taking protease inhibitors have been found to have higher levels of fat in their blood than is normal, which can cause heart problems. It is hoped that giving lipid-lowering drugs can help prevent serious heart problems. First, however, it is important to see what happens when protease inhibitors and lipid-lowering drugs are given together.

Conditions

HIV Infections

Keywords

Drug Interactions; HIV Protease Inhibitors; Ritonavir; HIV Seronegativity; Saquinavir; Nelfinavir; Anticholesteremic Agents

Interventions

Pravastatin sodium DRUG

Simvastatin DRUG

Atorvastatin calcium DRUG

Ritonavir DRUG

Nelfinavir mesylate DRUG

Saquinavir DRUG

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• You may be eligible for this study if you:
• Are HIV-negative.
• Are between the ages of 18 and 60.
• Agree to use a barrier method of birth control (e.g., a condom) during the study.

You may not qualify if:

• You will not be eligible for this study if you:
• Have a history of a chronic illness such as high blood pressure, heart disease, arthritis, or diabetes.
• Are pregnant or breast-feeding.
• Are taking certain medications.

Sponsors & Collaborators

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

Study Sites (13)

Univ of Southern California / LA County USC Med Ctr

Los Angeles, California, 900331079, United States

Location

San Francisco Gen Hosp

San Francisco, California, 941102859, United States

Location

Stanford Univ Med Ctr

Stanford, California, 943055107, United States

Location

Univ of Colorado Health Sciences Ctr

Denver, Colorado, 80262, United States

Location

Univ of Miami School of Medicine

Miami, Florida, 331361013, United States

Location

Univ of Hawaii

Honolulu, Hawaii, 96816, United States

Location

Indiana Univ Hosp

Indianapolis, Indiana, 462025250, United States

Location

Tulane Univ School of Medicine

New Orleans, Louisiana, 70112, United States

Location

Johns Hopkins Hosp

Baltimore, Maryland, 21287, United States

Location

Univ of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Bellevue Hosp / New York Univ Med Ctr

New York, New York, 10016, United States

Location

Julio Arroyo

West Columbia, South Carolina, 29169, United States

Location

Univ of Washington

Seattle, Washington, 98104, United States

Location

Related Publications (2)

• Fichtenbaum CJ, Gerber JG, Rosenkranz SL, Segal Y, Aberg JA, Blaschke T, Alston B, Fang F, Kosel B, Aweeka F; NIAID AIDS Clinical Trials Group. Pharmacokinetic interactions between protease inhibitors and statins in HIV seronegative volunteers: ACTG Study A5047. AIDS. 2002 Mar 8;16(4):569-77. doi: 10.1097/00002030-200203080-00008.

  PMID: 11873000 BACKGROUND

• Wanke C. Pharmacokinetic interactions between protease inhibitors and statins in HIV seronegative volunteers: ACTG Study A5047, by Fichtenbaum et al. AIDS. 2003;17 Suppl 4:S109-10. No abstract available.

  PMID: 15080191 BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

Pravastatin; Simvastatin; Atorvastatin; Ritonavir; Nelfinavir; 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)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Lovastatin; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Thiazoles; Sulfur Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Quinolines

Study Officials

• Francesca Aweeka

  STUDY CHAIR

• Carl Fitchenbaum

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: March 1, 2002
• Last Updated: October 29, 2021

Record last verified: 2021-10

Locations

US (13)