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

Primary Purpose

HIV Infections

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tucaresol
Sponsored by
Aaron Diamond AIDS Research Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV-1, Immunity, Cellular, Drug Therapy, Combination, CD4-Positive T-Lymphocytes, Antigens, Anti-HIV Agents, Viral Load, tucaresol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rockefeller Univ

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 11, 2000
Last Updated
June 23, 2005
Sponsor
Aaron Diamond AIDS Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT00006209
Brief Title
A Study of Tucaresol in HIV-Infected Patients Who Are Taking Other Anti-HIV Drugs
Official Title
A Phase I Open-Label Dose Escalation Trial of Tucaresol in HIV-1 Infected Subjects Taking Potent Antiretroviral Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2001
Overall Recruitment Status
Unknown status
Study Start Date
June 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Aaron Diamond AIDS Research Center

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV-1, Immunity, Cellular, Drug Therapy, Combination, CD4-Positive T-Lymphocytes, Antigens, Anti-HIV Agents, Viral Load, tucaresol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
24 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tucaresol

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Rockefeller Univ
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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

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