Randomized Controlled Trial of a Protein-calorie Supplement for HIV-infected Women With Tuberculosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- HIV
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Enrollment
- 151
- Locations
- 1
- Primary Endpoint
- Change in CD4 Count
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The objective of this randomized, controlled trial is to determine if adding a protein-calorie supplement (PCS) to the standard treatments for tuberculosis (TB) and HIV will improve health outcomes. The investigators will enroll 180 HIV-positive women with newly diagnosed active TB and without prior anti-retroviral therapy (ART). At baseline, the investigators will conduct dietary interviews, measure body composition, randomize subjects to receive a PCS (plus micronutritional supplements [MNS]) or control (MNS only) for the 6-month duration of anti-TB therapy (ATT) plus an additional 2 mos (8 mos total). Subjects will be followed monthly and have CD4 counts at baseline, 2, 8 and 12 months. At 2 months (i.e., at the end of the 4 drug intensive phase of TB treatment and start of the 2 drug continuation phase), all subjects will be started on anti-retroviral therapy (ART) based on Tanzanian Ministry of Health guidelines (currently: AZT/3TC/efavirenz). The primary endpoint will be change in CD4 count after 8 months (i.e., at end of PCS/MNS intervention and 2 months after completion of ATT).
Detailed Description
The objective of this randomized, controlled trial is to determine if adding a protein-calorie supplement (PCS) to the standard treatments for tuberculosis (TB) and HIV will improve health outcomes. The investigators will enroll 180 HIV-positive women with newly diagnosed active TB and without prior anti-retroviral therapy (ART). At baseline, the investigators will conduct dietary interviews, measure body composition, randomize subjects to receive a PCS (plus micronutritional supplements \[MNS\]) or control (MNS only) for the 6-month duration of anti-TB therapy (ATT) plus an additional 2 mos (8 mos total). Subjects will be followed monthly and have CD4 counts at baseline, 2, 8 and 12 months. At 2 months (i.e., at the end of the 4 drug intensive phase of TB treatment and start of the 2 drug continuation phase), all subjects will be started on anti-retroviral therapy (ART) based on Tanzanian Ministry of Health guidelines (currently: AZT/3TC/efavirenz). The primary endpoint will be change in CD4 count after 8 months (i.e., at end of PCS/MNS intervention and 2 months after completion of ATT).
Investigators
C. Fordham von Reyn
Staff Physician
Dartmouth-Hitchcock Medical Center
Eligibility Criteria
Inclusion Criteria
- •age \> 18,
- •CD4 \> 50,
- •new TB diagnosis,
- •not on anti-retroviral therapy,
- •residence in Dar es Salaam
Exclusion Criteria
- •current anti-retroviral therapy,
- •serious co-morbidities
Outcomes
Primary Outcomes
Change in CD4 Count
Time Frame: Baseline to 8 months
We will calculate change in CD4 count from start of ART until 6 mos on ART (which is started 2 mos after study enrollment, hence 8 mos after enrollment)
Secondary Outcomes
- BMI at 6 Months(baseline to 6 months)
- Number of Subjects Who Achieve 100 Cell Increase in CD4(baseline to 8 months)