Effects of a Protein Calorie Supplement in HIV-infected Women With Tuberculosis
- Conditions
- TuberculosisHIV
- Interventions
- Dietary Supplement: Protein calorie supplementDietary Supplement: Micronutrient
- Registration Number
- NCT01635153
- Lead Sponsor
- Dartmouth-Hitchcock Medical Center
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 151
- female,
- HIV,
- age > 18,
- CD4 > 50,
- BMI>16
- new TB diagnosis,
- not on anti-retroviral therapy,
- residence in Dar es Salaam
- current anti-retroviral therapy,
- serious co-morbidities
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Protein calorie supplement plus micronutrient Protein calorie supplement - Micronutrient alone Micronutrient -
- Primary Outcome Measures
Name Time Method Change in CD4 Count 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 Outcome Measures
Name Time Method BMI at 6 Months baseline to 6 months BMI will be compared between the two treatment groups
Number of Subjects Who Achieve 100 Cell Increase in CD4 baseline to 8 months Number of subjects in 2 treatment groups who achieve 100 cell increase in CD4 will be compared
Trial Locations
- Locations (1)
Infectious Disease Centre
🇹🇿Dar es Salaam, Tanzania