Effectiveness of Anti-HIV Therapy (HAART) in HIV-Infected Patients With Tuberculosis
Viral and Immune Dynamics in HIV-Infected Patients With Tuberculosis
2 other identifiers
interventional
44
1 country
10
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 hiv-infections
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedSeptember 11, 2008
June 1, 2003
February 25, 2000
September 10, 2008
Conditions
Keywords
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079, United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325, United States
Cook County Hosp
Chicago, Illinois, 60612, United States
Beth Israel Med Ctr
New York, New York, 10003, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016, United States
Columbia Presbyterian Med Ctr
New York, New York, 10032, United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Brown Univ / Miriam Hosp
Providence, Rhode Island, 02906, United States
Miriam Hosp / Brown Univ
Providence, Rhode Island, 02906, United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 37203, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Diane Havlir
- STUDY CHAIR
Constance Benson
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Purpose
- TREATMENT
- Sponsor Type
- NIH
Study Record Dates
First Submitted
February 25, 2000
First Posted
August 31, 2001
Last Updated
September 11, 2008
Record last verified: 2003-06