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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aaron Diamond AIDS Research Center

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.