Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

Effects of Ribavirin on Zidovudine or Stavudine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00021632
First received: July 26, 2001
Last updated: July 19, 2013
Last verified: July 2013
History of Changes
  Purpose

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.


Condition
HIV Infections
Hepatitis C

Study Type: Observational
Official Title: Pharmacokinetic Evaluation of the Effects of Ribavirin (RBV) on Zidovudine (ZDV) or Stavudine (d4T) Triphosphate (TP) Formation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):
Estimated Enrollment: 32
Detailed Description:

RBV, a nucleoside analogue, is used for the treatment of hepatitis C virus (HCV) in alliance with interferon-alfa 2a/2b in patients with HIV-1. The mechanism of action of RBV has led to in vitro studies examining the agonism/antagonism in efficacy occurring when used in combination with nucleoside reverse transcriptase inhibitors (NRTIs). The primary objective of the pharmacology component of this current study will be the evaluation of the effect of RBV on the intracellular activation of ZDV or d4T owing to the reported antagonism observed in vitro.

Pharmacokinetic (PK) evaluations for plasma ZDV or d4T and intracellular ZDV or d4T and measurements of their triphosphate anabolites are performed before initial RBV dosing (within 2 weeks of visit) and 8 weeks after RBV administration. Thymidine triphosphate (TTP) concentrations also are quantitated to permit estimation of the ratio of active drug to endogenous triphosphate concentrations.

For entry, prior to RBV dosing, blood samples are collected within 2 hours prior to the ZDV or d4T dose and then at Hours 1, 4, and 8 post dosing. Following the entry PK blood draws, patients initiate RBV treatment within 2 weeks of the first PK study day.

For the Week 8 evaluation (measured as 8 weeks following initiation of RBV), blood samples are collected prior to the ZDV or d4T dose and then at Hours 1, 4, and 8 post dosing.

  Eligibility
Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

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).

Exclusion Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00021632

Locations
United States, California
UCLA CARE Ctr
Los Angeles, California, United States, 90095
San Mateo AIDS Program / Stanford Univ
Stanford, California, United States, 943055107
Stanford Univ Med Ctr
Stanford, California, United States, 943055107
Willow Clinic / Stanford Univ
Stanford, California, United States, 94305
United States, Maryland
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287
United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109-1998
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Study Chair: Francesca Aweeka
  More Information

Additional Information:
Click here for more information on ribavirin  This link exits the ClinicalTrials.gov site
Click here for more information about stavudine  This link exits the ClinicalTrials.gov site
Click here for more information on zidovudine  This link exits the ClinicalTrials.gov site
Haga clic aquí para ver información sobre este ensayo clínico en español.  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00021632     History of Changes
Other Study ID Numbers: ACTG A5092s, AACTG A5092s, ACTG A5092s, 10919
Study First Received: July 26, 2001
Last Updated: July 19, 2013
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Ribavirin
Drug Interactions
Drug Therapy, Combination
Zidovudine
Stavudine
 Reverse Transcriptase Inhibitors
Anti-HIV Agents
Pharmacokinetics
Area Under Curve

ClinicalTrials.gov processed this record on March 03, 2015