A Study of Tucaresol in HIV-Infected Patients Who Are Taking Other Anti-HIV Drugs

June 23, 2005 updated by: Aaron Diamond AIDS Research Center

A Phase I Open-Label Dose Escalation Trial of Tucaresol in HIV-1 Infected Subjects Taking Potent Antiretroviral Therapy

The purpose of this study is to see if it is safe to give tucaresol to HIV-infected patients who are taking combination anti-HIV therapy (HAART). This study also examines the effect tucaresol has on viral load (level of HIV in the body) when tucaresol is used with HAART.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients are enrolled sequentially into the next available dosage cohort. Each cohort receives a single dose of tucaresol, is observed for 2 weeks, and then receives 3 alternate-day doses of drug and careful safety monitoring, including 4 weeks follow-up after the final dose. Dose cohorts receive drug sequentially, the lowest-dose cohort receiving the drug first. Dose escalation may not proceed to the next higher-dose cohort until all patients from the prior lower-dose cohort have completed the 4-week follow-up after the multiple dosing, adverse events are within the described bounds, and the FDA has reviewed the safety information from the treated cohort and approved the dose escalation. The drug is administered 4 times within the 8 weeks of the study period. Weekly visits are required. Patients receive financial compensation.

Study Type

Interventional

Enrollment

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Rockefeller Univ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Patients may be eligible for this study if they:

  • Are at least 18 years old.
  • Are HIV-positive.
  • Have more than 300 CD4 T cells/microL at screening.
  • Are taking certain anti-HIV drugs.
  • Have been taking these anti-HIV drugs successfully for at least 6 months.
  • Do not expect to change their anti-HIV therapy while they are in the study.
  • Have had plasma viral load less than 50 copies/ml while on their anti-HIV therapy.
  • Have viral load that cannot be detected at screening and baseline tests.
  • Are able to complete weekly visits.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Cannot give informed consent.
  • Have abnormal laboratory test results at baseline.
  • Are pregnant or breast-feeding.
  • Have had certain short-term or long-term illnesses (such as heart disease, sickle cell disease, anemia, or lung problems).
  • Have received a vaccination within the 30 days prior to enrollment.
  • Have received any other experimental drug within 60 days of enrollment.
  • Are taking abacavir (Ziagen, GW1592) or drugs that affect the immune system, such as IL-2, GM-CSF, corticosteroids, or cyclosporine.
  • Have a history of tumors.
  • Are actively using illegal drugs (methadone is allowed).
  • Have hepatitis B or hepatitis C.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aaron Diamond AIDS Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2000

Study Registration Dates

First Submitted

September 11, 2000

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

June 1, 2001

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 311A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Clinical Trials on Tucaresol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe