- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004736
Effectiveness of Anti-HIV Therapy (HAART) in HIV-Infected Patients With Tuberculosis
Viral and Immune Dynamics in HIV-Infected Patients With Tuberculosis
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.
Study Overview
Status
Conditions
Detailed Description
Previous studies have focused on characterizing viral and immune dynamics after initiation of HAART in patients without opportunistic infection. The development of TB in HIV-infected individuals is associated with an elevation in HIV RNA levels, a decrease in CD4 cell counts, and an increase in activated (CD38) lymphocytes and proinflammatory cytokines (IL-1, TNF-alpha, and IL-6). Response to HAART may differ in individuals with an active opportunistic infection such as TB.
HIV-infected patients with active TB follow an anti-TB regimen including rifabutin and are observed for a maximum of 24 weeks before they initiate HAART. Plasma samples for 24-hour post-rifabutin dosing are collected at entry and at Weeks 4, 8, and 12, then again at Weeks 2, 3, 4, 12, and 24 after HAART initiation. Analyses of these samples are used to explore the relationship between cytokines and rifabutin metabolism and the effect of nelfinavir on rifabutin pharmacokinetics. The HAART regimen is nelfinavir plus lamivudine (3TC) plus either zidovudine (ZDV) or stavudine (d4T). After initiation of HAART, all patients undergo intensive monitoring of viral and immune dynamics for 2 months. The patients continue to be followed for 1 year from the time of starting HAART. Neither the HAART drug regimen nor anti-TB medications will be provided by the study and must be obtained by prescription. If patients are intolerant of the HAART regimen or exhibit virologic rebound, primary providers can alter or modify this regimen. As part of substudy A5065s, patients who experience signs or symptoms of paradoxical reactions (i.e., new persistent fevers that develop after initiating HAART and which last for more than 1 week without an identifiable source; marked worsening or emergence of intrathoracic lymphadenopathy, pulmonary infiltrates; worsening or emergence of cervical adenopathy on serial physical examinations; or worsening of other tuberculous lesions) have additional clinical evaluations (including a chest x-ray, a target clinical assessment, concomitant medications, and signs and symptoms) weekly for 4 weeks, then every month thereafter until the symptoms resolve.
Study Type
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 900331079
- Univ of Southern California / LA County USC Med Ctr
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San Diego, California, United States, 921036325
- Univ of California / San Diego Treatment Ctr
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Illinois
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Chicago, Illinois, United States, 60612
- Cook County Hosp
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New York
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New York, New York, United States, 10003
- Beth Israel Med Ctr
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New York, New York, United States, 10016
- Bellevue Hosp / New York Univ Med Ctr
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New York, New York, United States, 10032
- Columbia Presbyterian Med Ctr
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Univ of Pennsylvania at Philadelphia
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Rhode Island
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Providence, Rhode Island, United States, 02906
- Brown Univ / Miriam Hosp
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Providence, Rhode Island, United States, 02906
- Miriam Hosp / Brown Univ
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Tennessee
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Nashville, Tennessee, United States, 37203
- Vanderbilt Univ Med Ctr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Investigators
- Study Chair: Diane Havlir
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Actinomycetales Infections
- Mycobacterium Infections
- Tuberculosis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antimetabolites
- Protease Inhibitors
- Hypolipidemic Agents
- Lipid Regulating Agents
- Anti-Bacterial Agents
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Antitubercular Agents
- Antibiotics, Antitubercular
- Fatty Acid Synthesis Inhibitors
- Lamivudine
- Zidovudine
- Stavudine
- Rifabutin
- Nelfinavir
- Isoniazid
- Pyrazinamide
- Ethambutol
Other Study ID Numbers
- ACTG A5062
- AACTG A5062
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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