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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2001 by NIH AIDS Clinical Trials Information Service.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00006209
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
  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 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00006209     History of Changes
Other Study ID Numbers: 311A
First Submitted: September 11, 2000
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
Last Verified: June 2001

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:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases