Effects of Ribavirin on Zidovudine or Stavudine

Completed

Conditions studied: HIV Infections, Hepatitis C

In brief

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.

Key facts

Study ID

NCT00021632

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

32

Last updated by the study team

2015-05-19

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• UCLA CARE Ctr — Los Angeles, California, United States
• San Mateo AIDS Program / Stanford Univ — Stanford, California, United States
• Stanford Univ Med Ctr — Stanford, California, United States
• Willow Clinic / Stanford Univ — Stanford, California, United States
• Johns Hopkins Hosp — Baltimore, Maryland, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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