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| Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00703404 |
Purpose
This study will evaluate the effectiveness of first-line HIV treatment (fixed-dose combination of the generic antiretroviral drugs nevirapine, stavudine and lamivudine) provided by the Malian National HIV Treatment Program.
Antiretroviral therapy has become a priority because of its proven effectiveness in decreasing sickness and death from HIV infection. Reliable information on its efficacy is needed.
Patients 18 years of age and older who enter the Malian National HIV Treatment Program and have not had prior antiretroviral treatment may be eligible for this study.
Primary Objective
The primary objective is to measure the virologic treatment response at 24 weeks to the Malian-approved fixed-dose regimen (FDC) of nevirapine, stavudine and lamivudine (Triomune) in patients who are na ve to antiretroviral therapy in Bamako, Mali compared to a historical cohort as a prelude to further clinical research investigations in Mali.
Secondary Objectives
Participants undergo treatment in the government-sponsored program. Clinical visits are scheduled at study days 0 (antiviral therapy start day) and 14, and at 1, 3, 6, 9 and 12 months. Patients undergo a medical history, including all confirmed and probably diagnoses made since the previous visit and current status, physical examination and blood tests for CD4 and viral load at each visit.
Study start date: July 2008
| Condition |
|---|
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HIV Infections |
| Study Type: | Observational |
| Study Design: | Prospective |
| Official Title: | A Cohort Observational Study to Assess the Virologic Response to Standard HIV Treatment in Bamako, Mali |
| Estimated Enrollment: | 100 |
| Study Start Date: | June 2008 |
| Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
This study will assess the efficacy of HIV treatment provided in accordance with the Malian National HIV Treatment Program. The Malian National HIV Treatment Program uses fixed-dose combination (FDC) generic antiretroviral therapy, and this study will use a historical comparison from an African country in which the same FDC is used. Virologic responses of patients enrolled in the Malian national program will be determined and, in a non-inferiority design, compared to these historical controls. The study will also establish the feasibility of doing frequent HIV virologic monitoring in this setting.
Viral RNA and CD4 T-cell count monitoring will be performed for HIV-infected persons seen at study sites. All clinical decision-making and prescription will occur outside of the protocol. Decisions about whether antiretroviral therapy is appropriate, the prescription of antiretroviral therapy, and the monitoring of treatment will be done by Malian health-care providers outside of the scope of the protocol. Viral RNA monitoring will be used to assess the endpoint of viral RNA suppression below the limit of detection (50 copies/mL).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
HIV-infected adults (age greater than or equal to 18 years) naive to treatment with antiretroviral medications, who are to begin the fixed-dose regimen of nevirapine, stavudine, and lamivudine government-sponsored antiretroviral treatment program.
The sole exception to naive will be a history of use of peripartum single-dose nevirapine.
Hemoglobin greater than or equal to 8 g/dL
Ability and willingness to provide informed consent and ability to comply with study requirements and visit schedule.
Must be willing to allow stored samples to be used in the future for studying HIV disease and immune function.
EXCLUSION CRITERIA:
Serologic evidence of HIV-2 infection, which precludes the use of the nevirapine-based FDC.
Tuberculosis of any form for which the patient is currently undergoing treatment with or requires a recommended regimen containing a rifamycin antibiotic.
Baseline medical conditions that preclude the use of the Malian fixed-dose regimen, such as peripheral neuropathy of any etiology and pancreatic disease.
Contacts and Locations| Contact: Susan M. Orsega, C.R.N.P. | (301) 402-7032 | sorsega@nih.gov |
| United States, Maryland | |
| National Institute of Allergy and Infectious Diseases (NIAID), 9000 Rockville Pi | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
More Information
| Study ID Numbers: | 999908160, 08-I-N160 |
| Study First Received: | June 20, 2008 |
| Last Updated: | August 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00703404 History of Changes |
| Health Authority: | United States: Federal Government |
|
Anti-Retroviral Therapy HIV Virologic Response HIV Treatment Naïve |
|
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
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Virus Diseases Sexually Transmitted Diseases, Viral RNA Virus Infections Slow Virus Diseases Immune System Diseases HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Lentivirus Infections Infection Retroviridae Infections Immunologic Deficiency Syndromes |
