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NCT00877591 · ClinicalTrials.gov registry record · Phase 1

Interaction of Buprenorphine With HIV Medications and Tuberculosis Medications

A Phase 1 study, sponsored by University of California, San Francisco.

Completed
Registry status
Phase 1
Development phase
63
Enrollment target

NCT00877591 is a Phase 1 study that has completed, run by University of California, San Francisco. The registered enrollment target is 63 participants.

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The verdict

NCT00877591, a Phase 1 study, has completed, sponsored by University of California, San Francisco.

COMPLETED
Registry status
Phase 1
Development phase
63 participants
Enrollment target

Study Summary

The purpose of this study is to examine the interactions of buprenorphine-naloxone, a medication used to treat opiate (heroin or prescription narcotic) dependence, and medications used in the treatment of HIV disease including atazanavir (Reyataz), fosamprenavir (Lexiva), didanosine (Videx), tenofovir (Viread), atazanavir (Reyataz)/ritonavir (Norvir), fosamprenavir (Lexiva)/ritonavir (Norvir), lamivudine (Epivir), or darunavir (please note that we have completed drug interaction studies for buprenorphine with atazanavir, atazanavir/ritonavir, didanosine, tenofovir and lamivudine) at the PI's previous university; for this CHR application only the studies needed to be completed at UCSF/SFGH will be discussed) or tuberculosis(TB) (rifampin or rifabutin) medications (note: supplement application currently pending). Participants are those with opioid dependence who qualify for buprenorphine/naloxone treatment or they are healthy subjects without opioid dependence who participate in pharmacokinetics studies of the antiretroviral medications. A total of 160 such individuals will be enrolled in these studies (please note that the studies have been ongoing at Virginia Commonwealth University for 3 years so that the total number of participants to be recruited at UCSF/SFGH will be about 50 protocol completers). Participants take the HIV or tuberculosis medicine(s) for up to 15 days (depending on the medication(s) administered and ability to schedule blood and urine sampling sessions).

Interventions

  • DRUG Rifampin
  • DRUG Buprenorphine
  • DRUG Rifabutin
  • DRUG Darunavir/Ritonavir
  • DRUG Fosamprenavir/Ritonavir

Trial Details

FieldValue
Enrollment Target 63 participants
Start Date 2008-04
Est. Completion 2013-04
Phase Phase 1

What the Registry Record Tells You About NCT00877591

The ClinicalTrials.gov registry entry for NCT00877591 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Rifampin is the first listed.

NCT00877591 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00877591 about?

NCT00877591 is a clinical study titled "Interaction of Buprenorphine With HIV Medications and Tuberculosis Medications". The purpose of this study is to examine the interactions of buprenorphine-naloxone, a medication used to treat opiate (heroin or prescription narcotic) dependence, and medications used in the treatment of HIV disease including atazanavir (Reyataz), fosamprenavir (Lexiva), didanosine (Videx), tenofov...

What is the current status of trial NCT00877591?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 63 participants. The study started on 2008-04. Estimated completion is 2013-04.

What interventions are being tested in trial NCT00877591?

The interventions under investigation include: Rifampin (DRUG), Buprenorphine (DRUG), Rifabutin (DRUG), Darunavir/Ritonavir (DRUG), Fosamprenavir/Ritonavir (DRUG).

Who is sponsoring clinical trial NCT00877591?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.