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| Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Makerere University |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00078247 |
Purpose
This study is designed to determine whether 6 months of anti-HIV drugs given along with tuberculosis treatment will delay the onset of AIDS in HIV infected African patients.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections Tuberculosis |
Drug: Abacavir Drug: Lamivudine Drug: Zidovudine Drug: Tuberculosis treatment |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Delaying HIV Disease Progression With Punctuated Antiretroviral Therapy in HIV-Associated Tuberculosis |
| Estimated Enrollment: | 350 |
| Study Start Date: | October 2004 |
| Estimated Study Completion Date: | September 2011 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Participants will receive 6 months of ARV therapy and treatment for TB
|
Drug: Abacavir
300 mg tablet taken orally twice daily
Drug: Lamivudine
300 mg tablet taken orally daily
Drug: Zidovudine
300 mg tablet taken orally twice daily
Drug: Tuberculosis treatment
Tuberculosis treatment
|
|
2: Experimental
Participants will not receive ARV therapy until CD4 counts drop below 250 cells/mm3. All participants will receive treatment for TB.
|
Drug: Abacavir
300 mg tablet taken orally twice daily
Drug: Lamivudine
300 mg tablet taken orally daily
Drug: Zidovudine
300 mg tablet taken orally twice daily
Drug: Tuberculosis treatment
Tuberculosis treatment
|
Tuberculosis (TB) is a common and serious complication of HIV infection in the developing world, especially in sub-Saharan Africa. Since the emergence of the HIV epidemic in Africa, the incidence rates of TB have risen dramatically, overwhelming national TB control programs across the continent. Over 50% of TB patients presenting to TB clinics in Africa are HIV infected. These patients often present in the early stages of HIV infection.
Recent World Health Organization guidelines on the management of HIV-associated pulmonary TB recommend antiretroviral (ARV) therapy in patients with CD4 cells less than 200 cells/mm3, but not for HIV infected TB patients who present with a high CD4 count. In Uganda, over half of HIV infected patients with active TB present to TB clinics with CD4 counts above 200 cells/mm3, and there is evidence that coinfected patients with a high CD4 count should be treated with ARV therapy. First, mortality in HIV-associated TB is high, even when patients respond to effective anti-tuberculosis therapy. Second, excess mortality associated with TB is most evident when CD4 counts are above 200 cell/mm3. Third, in coinfected patients, TB results in prolonged immune activation, which may enhance viral replication and accelerate the decline of CD4 cells.
This study will evaluate whether short-term ARV therapy of abacavir sulfate, lamivudine, and zidovudine given during treatment of active TB will slow progression of HIV disease in TB patients with CD4 counts of at least 350 cells/mm3. The study will also assess the possible risks (e.g., drug toxicities and resistance) and benefits (e.g., more rapid clearance of mycobacterium tuberculosis and reduced TB relapse) of punctuated ARV therapy.
Participants in this study will be HIV infected TB patients with CD4 counts of at least 350 cells/mm3. All participants will receive treatment for TB. Participants will be randomly assigned to receive 6 months of ARV therapy or to delay ARV therapy until CD4 counts drop below 250 cells/mm3. The participants will be followed for 2 years; CD4 counts will be compared between groups.
This study will also follow a group of HIV infected patients without active TB to quantify the extent to which CD4 cell decline is accelerated with active TB and to determine the extent to which a decline is neutralized in patients who receive punctuated ARV therapy.
Eligibility| Ages Eligible for Study: | 13 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Christopher C. Whalen, MD | ccw@case.edu |
| Uganda | |
| Makerere University Medical School | Recruiting |
| Kampala, Uganda | |
| Contact: Roy Mugerwa, MD profrdm@imul.com | |
| Principal Investigator: | Christopher C. Whalen, MD | Case Western Reserve University |
| Principal Investigator: | Roy Mugerwa, MD | Makerere University |
| Principal Investigator: | Diane Havlir, MD | University of California, San Francisco |
More Information
| Responsible Party: | Case Western Reserve University ( Christopher C. Whalen, MD ) |
| Study ID Numbers: | 1R01AI051219-01A2, 1 R01 AI051219-01A2 |
| Study First Received: | February 20, 2004 |
| Last Updated: | September 25, 2008 |
| ClinicalTrials.gov Identifier: | NCT00078247 |
| Health Authority: | United States: Federal Government |
|
Antiretroviral Therapy Africa |
|
Bacterial Infections Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome Disease Progression Lamivudine Zidovudine Immunologic Deficiency Syndromes Virus Diseases |
Gram-Positive Bacterial Infections HIV Infections Sexually Transmitted Diseases Mycobacterium Infections Tuberculosis Abacavir Retroviridae Infections |
|
Antimetabolites Anti-Infective Agents RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Infection |
Antiviral Agents Actinomycetales Infections Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |
