Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-25 @ 7:08 PM
Study NCT ID:
NCT00703404
Status:
COMPLETED
Last Update Posted:
2018-04-05
First Post:
2008-06-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Response to Standard HIV Treatment in Bamako, Mali
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Organization:
Study Overview
Official Title:
A Cohort Observational Study to Assess the Virologic Response to Standard HIV Treatment in Bamako, Mali
Status:
COMPLETED
Status Verified Date:
2016-02-24
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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(SqrRoot) ve to antiretroviral therapy in Bamako, Mali compared to a historical cohort as a prelude to further clinical research investigations in Mali.
Secondary Objectives
1. To assess the association of the 24 week response with the response at one year as measured by suppression of viremia to less than 50 copies/mL
2. To evaluate the baseline clinical and HIV-associated characteristics of a cohort of persons who are enrolled in protocol-mandated monitoring.
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
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(SqrRoot) ve to antiretroviral therapy in Bamako, Mali compared to a historical cohort as a prelude to further clinical research investigations in Mali.
Secondary Objectives
1. To assess the association of the 24 week response with the response at one year as measured by suppression of viremia to less than 50 copies/mL
2. To evaluate the baseline clinical and HIV-associated characteristics of a cohort of persons who are enrolled in protocol-mandated monitoring.
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
Detailed Description:
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 fixe dose coninaison (FDC) therapy, and this study will use a historical comparison from an African country in which the same generic antiretoviral are 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).
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).
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 08-I-N160 | None | None | View |