Clinical trial NCT01635153: Effects of a Protein Calorie Supplement in HIV-infected Women With Tuberculosis
Official title: Randomized Controlled Trial of a Protein-calorie Supplement for HIV-infected Women With Tuberculosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Tuberculosis
Keywords: HIV
Tuberculosis
Nutrition
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2012-07-09
Enrollment: 151
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Protein-calorie supplement plus micronutrient vs micronutrient alone
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in CD4 Count
timeFrame: Baseline to 8 months
Secondary outcomes:
measure: BMI at 6 Months
timeFrame: baseline to 6 months
measure: Number of Subjects Who Achieve 100 Cell Increase in CD4
timeFrame: baseline to 8 months
Other outcomes:
Locations:
city: Dar es Salaam
country: Tanzania
facility: Infectious Disease Centre
Study officials:
affiliation: Dartmouth College
name: Charles F. von Reyn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Muhimbili University of Health and Allied Sciences
name: Nyasule Majura-Neke, MD
role: STUDY_DIRECTOR
References:
citation: Magohe A, Kimario J, Lukmanji Z, Hendricks K, Koethe JR, Neke NM, Tvaroha S, Connor R, Mackenzie T, Waddell R, Maro I, Matee M, Pallangyo K, Bakari M, Horsburgh CR, von Reyn CF. Randomized, controlled trial of a protein-calorie supplement for women coinfected with HIV-TB. Int J Tuberc Lung Dis. 2022 Aug 1;26(8):798-800. doi: 10.5588/ijtld.21.0669. No abstract available.