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A Study of Tucaresol in HIV-Infected Patients Who Are Taking Other Anti-HIV Drugs Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about A Study of Tucaresol in HIV-Infected Patients Who Are Taking Other Anti-HIV Drugs conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Study of Tucaresol in HIV-Infected Patients Who Are Taking Other Anti-HIV Drugs Clinical research trials and A Study of Tucaresol in HIV-Infected Patients Who Are Taking Other Anti-HIV Drugs health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like A Study of Tucaresol in HIV-Infected Patients Who Are Taking Other Anti-HIV Drugs. A Study of Tucaresol in HIV-Infected Patients Who Are Taking Other Anti-HIV Drugs Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a A Study of Tucaresol in HIV-Infected Patients Who Are Taking Other Anti-HIV Drugs clinical trial. Subjects frequently get the best healthcare possible for their A Study of Tucaresol in HIV-Infected Patients Who Are Taking Other Anti-HIV Drugs condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.

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



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

For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): Aaron Diamond AIDS Research Center ,
Synopsis: 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.
Details: 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:
Study Type:
  Interventional, Treatment, Dose Comparison, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 24

Location and Contact Information:

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


Additional Information:
Study ID Numbers:
  311A; 
Study Start Date: June 2000
Record last reviewed: June 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006209

Other Hiv Infections Studies:
1. Granulocyte-Macrophage Colony-Stimulating Factor and Zidovudine: A Phase I Study of Concurrent Administration in Patients With AIDS and Severe ARC

2. A Double-Blind, Randomized, Dose Response Study of Three Doses of Delavirdine Mesylate (U-90152S) in Combination with Zidovudine (ZDV) versus ZDV alone in HIV-1 Infected Individuals with CD4 Counts of 200-500mm3

3. The Safety of Tenofovir Disoproxil Fumarate Taken with Other Anti-HIV Drugs to Treat HIV-Infected Patients

4. A Phase II Trial of rsCD4 and AZT in Patients With AIDS or Advanced AIDS Related Complex (ARC)

5. A Phase I Study of the Safety of Proleukin (aldesleukin) in Combination with Ganciclovir and Antiretroviral Therapy in HIV Seropositive Patients With Cytomegalovirus (CMV) Retinitis

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