HIV InfectionsNCT00021632
Effects of Ribavirin on Zidovudine or Stavudine
An observational study of HIV Infections and Hepatitis C, run by National Institute of Allergy and Infectious Diseases (NIAID) at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections, Hepatitis C
- How many people
- 32 participants
- Where
- 6 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Johns Hopkins Hosp
Baltimore, Maryland, 21287
MetroHealth Medical Center
Cleveland, Ohio, 44109-1998
UCLA CARE Ctr
Los Angeles, California, 90095
San Mateo AIDS Program / Stanford Univ
Stanford, California, 943055107
Stanford Univ Med Ctr
Stanford, California, 943055107
Willow Clinic / Stanford Univ
Stanford, California, 94305
About this study
Official title: Pharmacokinetic Evaluation of the Effects of Ribavirin (RBV) on Zidovudine (ZDV) or Stavudine (d4T) Triphosphate (TP) Formation
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.
Read the 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.
- Conditions
- HIV Infections, Hepatitis C
- Keywords
- Ribavirin, Drug Interactions, Drug Therapy, Combination, Zidovudine, Stavudine, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Pharmacokinetics, Area Under Curve
- Medical subject headings
- HIV Infections, Hepatitis C
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 32 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Francesca Aweeka, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00021632
- Sponsor's protocol ID
- ACTG A5092s
- Other IDs
- AACTG A5092s, ACTG A5092s, 10919
- Status last verified
- Jul 2013
- First submitted
- 26 Jul 2001
- Last updated
- 19 May 2015
- Results posted
- No
Publications
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.
PubMed 17561874
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Evaluation of the Effects of Ribavirin (RBV) on Zidovudine (ZDV) or Stavudine (d4T) Triphosphate (TP) Formation
- ClinicalTrials.gov ID
- NCT00021632
- Acronym / sponsor ID
- ACTG A5092s
- Conditions
- HIV Infections, Hepatitis C
- Keywords
- Ribavirin, Drug Interactions, Drug Therapy, Combination, Zidovudine, Stavudine, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Pharmacokinetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2015.
- Results publication: PubMed 17561874Aweeka 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesca Aweeka study chair
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Hepatitis C, run by National Institute of Allergy and Infectious Diseases (NIAID) at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00021632, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2015.