Effects of Ribavirin on Zidovudine or Stavudine

NCT00021632 | Completed

• 3 other identifiers: ACTG A5092sAACTG A5092s10919
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to see how treatment of hepatitis C (HCV) patients with ribavirin (RBV) affects the anti-HIV drugs stavudine (d4T) or zidovudine (ZDV). Studies have shown that RBV may interfere with the action of ZDV and d4T. There is little information about the way these drugs interact in the body. This study will examine how the drug RBV affects levels of ZDV or d4T in patients who are currently on stable anti-HIV therapy.

Conditions

HIV Infections; Hepatitis C

Keywords

Ribavirin; Drug Interactions; Drug Therapy, Combination; Zidovudine; Stavudine; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Pharmacokinetics; Area Under Curve

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients may be eligible for this study if they:
• Are at least 13 years of age.
• Have written consent from parent or guardian if under 18 years of age.
• Have HIV infection.
• Have been receiving ZDV or d4T for at least 4 weeks prior to study entry.
• Are planning to receive RBV-containing hepatitis treatment through their doctor or through coenrollment in another ACTG protocol within 2 weeks following entry into the study.
• Have not received RBV for at least 6 months prior to study entry if they were previously treated with RBV.
• Weigh more than 110 pounds (50 kg).

You may not qualify if:

• Patients will not be eligible for this study if they:
• Are pregnant.
• Use rifampin, rifabutin, pyrazinamide, isoniazid, ganciclovir, or hydroxyurea within 14 days of study entry.
• Abuse alcohol or drugs. Patients in methadone programs may participate.

Sponsors & Collaborators

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

Study Sites (6)

UCLA CARE Ctr

Los Angeles, California, 90095, United States

Location

San Mateo AIDS Program / Stanford Univ

Stanford, California, 943055107, United States

Location

Stanford Univ Med Ctr

Stanford, California, 943055107, United States

Location

Willow Clinic / Stanford Univ

Stanford, California, 94305, United States

Location

Johns Hopkins Hosp

Baltimore, Maryland, 21287, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109-1998, United States

Location

Related Publications (1)

• Aweeka FT, Kang M, Yu JY, Lizak P, Alston B, Chung RT; AIDS Clinical Trials Group 5092s Study Team. Pharmacokinetic evaluation of the effects of ribavirin on zidovudine triphosphate formation: ACTG 5092s Study Team. HIV Med. 2007 Jul;8(5):288-94. doi: 10.1111/j.1468-1293.2007.00472.x.

  PMID: 17561874 RESULT

MeSH Terms

Conditions

HIV Infections; Hepatitis C

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; Hepatitis, Viral, Human; Flaviviridae Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Francesca Aweeka

  STUDY CHAIR

Study Design

• Study Type: observational
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2001
• First Posted: August 31, 2001
• Last Updated: May 19, 2015

Record last verified: 2013-07

Locations

US (6)