Effectiveness of Anti-HIV Therapy (HAART) in HIV-Infected Patients With Tuberculosis

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

Summary

The purpose of this study is to see if a type of anti-HIV therapy called HAART is effective in lowering levels of HIV and boosting the immune system in HIV-infected patients with tuberculosis (TB).

HIV-infected patients with TB have higher levels of HIV and lower CD4 cell counts (cells in the body that fight infection) than HIV-infected patients without TB. HAART has been effective in reducing HIV levels and increasing CD4 cells in patients without TB. However, its effects in HIV-infected patients with TB are unknown.

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

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Ethambutol; Isoniazid; Lamivudine; Nelfinavir; Pyrazinamide; Rifabutin; Stavudine; Zidovudine

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

• Are HIV-positive.

• Have an HIV RNA level of 20,000 copies/ml or more within 30 days of study entry.

• Are at least 18 years old.

• Agree to use an effective method of birth control during the study.

• Agree to be treated with rifabutin at least 2 weeks before starting HAART (applies only to patients infected with TB).

• Plan to start HAART within 6 months of starting TB therapy (applies only to patients infected with TB).

• Can take 3TC, nelfinavir, and either ZDV or d4T.

• Are available for follow-up for at least 1 year.

Exclusion Criteria

Patients will not be eligible for this study if they:

• Have taken a combination of anti-HIV drugs for greater than 3 months.

• Have started HAART since they were infected with TB (applies only to patients infected with TB).

• Are resistant to more than one medication used to treat TB (applies only to patients infected with TB).

• Have had more than 16 weeks of TB therapy (applies only to patients infected with TB).

• Are taking rifampin to treat TB and cannot switch to rifabutin at least 2 weeks before starting HAART (applies only to patients infected with TB).

• Are pregnant or breast-feeding.