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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00004736 |
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.
Condition | Intervention | Phase |
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HIV Infections Tuberculosis |
Drug: Nelfinavir mesylate Drug: Ethambutol hydrochloride Drug: Isoniazid Drug: Pyrazinamide Drug: Lamivudine Drug: Rifabutin Drug: Stavudine Drug: Zidovudine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Efficacy Study |
Official Title: | Viral and Immune Dynamics in HIV-Infected Patients With Tuberculosis |
Estimated Enrollment: | 44 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
United States, California | |
Univ of California / San Diego Treatment Ctr | |
San Diego, California, United States, 921036325 | |
Univ of Southern California / LA County USC Med Ctr | |
Los Angeles, California, United States, 900331079 | |
United States, Illinois | |
Cook County Hosp | |
Chicago, Illinois, United States, 60612 | |
United States, New York | |
Bellevue Hosp / New York Univ Med Ctr | |
New York, New York, United States, 10016 | |
Beth Israel Med Ctr | |
New York, New York, United States, 10003 | |
Columbia Presbyterian Med Ctr | |
New York, New York, United States, 10032 | |
United States, Pennsylvania | |
Univ of Pennsylvania at Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Rhode Island | |
Miriam Hosp / Brown Univ | |
Providence, Rhode Island, United States, 02906 | |
Brown Univ / Miriam Hosp | |
Providence, Rhode Island, United States, 02906 | |
United States, Tennessee | |
Vanderbilt Univ Med Ctr | |
Nashville, Tennessee, United States, 37203 |
Study Chair: | Diane Havlir | |
Study Chair: | Constance Benson |
Study ID Numbers: | ACTG A5062, AACTG A5062 |
Study First Received: | February 25, 2000 |
Last Updated: | September 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00004736 History of Changes |
Health Authority: | United States: Federal Government |
Tuberculosis Rifabutin AIDS-Related Opportunistic Infections |
Drug Therapy, Combination Antitubercular Agents Anti-HIV Agents |
Antimetabolites Bacterial Infections Opportunistic Infections Anti-Infective Agents Sexually Transmitted Diseases, Viral Rifabutin Stavudine Zidovudine Lamivudine Reverse Transcriptase Inhibitors Anti-Bacterial Agents Gram-Positive Bacterial Infections Anti-Retroviral Agents AIDS-Related Opportunistic Infections Tuberculosis |
Nelfinavir Retroviridae Infections Isoniazid HIV Protease Inhibitors Anti-HIV Agents Acquired Immunodeficiency Syndrome Pyrazinamide Antiviral Agents Immunologic Deficiency Syndromes Protease Inhibitors Virus Diseases HIV Infections Sexually Transmitted Diseases Mycobacterium Infections Ethambutol |
Antimetabolites Bacterial Infections Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Rifabutin Molecular Mechanisms of Pharmacological Action Zidovudine Lamivudine Infection Reverse Transcriptase Inhibitors Anti-Bacterial Agents Gram-Positive Bacterial Infections Anti-Retroviral Agents Therapeutic Uses |
Tuberculosis Nelfinavir Retroviridae Infections Nucleic Acid Synthesis Inhibitors HIV Protease Inhibitors RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Pyrazinamide Antiviral Agents Pharmacologic Actions Immunologic Deficiency Syndromes Actinomycetales Infections |