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

Completed · Phase 1

Conditions studied: HIV Infections, Tuberculosis

In brief

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.

Key facts

Study ID

NCT00004736

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

44

Last updated by the study team

2008-09-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Univ of Southern California / LA County USC Med Ctr — Los Angeles, California, United States
• Univ of California / San Diego Treatment Ctr — San Diego, California, United States
• Cook County Hosp — Chicago, Illinois, United States
• Beth Israel Med Ctr — New York, New York, United States
• Bellevue Hosp / New York Univ Med Ctr — New York, New York, United States
• Columbia Presbyterian Med Ctr — New York, New York, United States
• Univ of Pennsylvania at Philadelphia — Philadelphia, Pennsylvania, United States
• Brown Univ / Miriam Hosp — Providence, Rhode Island, United States
• Miriam Hosp / Brown Univ — Providence, Rhode Island, United States
• Vanderbilt Univ Med Ctr — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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