Effects of a Protein Calorie Supplement in HIV-infected Women With Tuberculosis

Study Overview
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Brief Summary
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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
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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).

Official Title
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Randomized Controlled Trial of a Protein-calorie Supplement for HIV-infected Women With Tuberculosis

Conditions
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HIV, Tuberculosis

Intervention / Treatment
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* Dietary Supplement: Protein calorie supplement
* Dietary Supplement: Micronutrient


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female, HIV, age > 18, CD4 > 50, BMI>16 new TB diagnosis, not on anti-retroviral therapy, residence in Dar es Salaam Exclusion Criteria: current anti-retroviral therapy, serious co-morbidities

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Protein-calorie supplement plus micronutrient vs micronutrient alone
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Protein calorie supplement plus micronutrient<br> | Dietary Supplement: Protein calorie supplement<br>* Fortified porridge with 1062 kcal and 40 gm protein<br>* Other names: Dar-uji;|
| Placebo Comparator: Micronutrient alone<br> | Dietary Supplement: Micronutrient<br>* Dar-vite Multivitamin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in CD4 Count | 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) | Baseline to 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI at 6 Months | BMI will be compared between the two treatment groups | baseline to 6 months | 
| Number of Subjects Who Achieve 100 Cell Increase in CD4 | Number of subjects in 2 treatment groups who achieve 100 cell increase in CD4 will be compared | baseline to 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Tuberculosis, Nutrition