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

This study is ongoing, but not recruiting participants.

First Received: September 11, 2000 Last Updated: June 23, 2005 History of Changes

Sponsor:	Aaron Diamond AIDS Research Center
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00006209

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: Tucaresol	Phase I

Study Type:	Interventional
Study Design:	Treatment, Dose Comparison, Safety Study
Official Title:	A Phase I Open-Label Dose Escalation Trial of Tucaresol in HIV-1 Infected Subjects Taking Potent Antiretroviral Therapy

Resource links provided by NLM:

MedlinePlus related topics: AIDS AIDS Medicines

Drug Information available for: Tucaresol

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:	24
Study Start Date:	June 2000

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006209

Locations

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

Sponsors and Collaborators

Aaron Diamond AIDS Research Center

More Information

No publications provided

Study ID Numbers:	311A
Study First Received:	September 11, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00006209 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

HIV-1
Immunity, Cellular
Drug Therapy, Combination
CD4-Positive T-Lymphocytes

Antigens
Anti-HIV Agents
Viral Load
tucaresol

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on November 30, 2009