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

Dartmouth Health

Status: Completed

Conditions: Tuberculosis; HIV

Treatments: Dietary Supplement: Micronutrient; Dietary Supplement: Protein calorie supplement

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01635153

RO1 503498 (Other Identifier)

DarDar 2-C CPHS 21592 D12221

Details and patient eligibility

About

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).

Full 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).

Enrollment: 151 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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151 participants in 2 patient groups, including a placebo group

Protein calorie supplement plus micronutrient

Active Comparator group

Treatment:

Dietary Supplement: Protein calorie supplement

Micronutrient alone

Placebo Comparator group

Treatment:

Dietary Supplement: Micronutrient