Randomized Controlled Trial of a Protein-calorie Supplement for HIV-infected Women With Tuberculosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 151
- Locations
- 1
- Primary Endpoint
- Change in CD4 Count
Study 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Micronutrient alone
Intervention: Micronutrient (Dietary Supplement)
Protein calorie supplement plus micronutrient
Intervention: Protein calorie supplement (Dietary Supplement)
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)
Investigators
C. Fordham von Reyn
Staff Physician
Dartmouth-Hitchcock Medical Center