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

NCT ID: NCT01635153

Last Updated: 2020-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 151 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2014-07-31

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).

Conditions

HIV; Tuberculosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Protein calorie supplement plus micronutrient

Group Type: ACTIVE_COMPARATOR

Protein calorie supplement

Intervention Type: DIETARY_SUPPLEMENT

Fortified porridge with 1062 kcal and 40 gm protein

Micronutrient alone

Group Type: PLACEBO_COMPARATOR

Micronutrient

Intervention Type: DIETARY_SUPPLEMENT

Dar-vite Multivitamin

Interventions

Protein calorie supplement

Fortified porridge with 1062 kcal and 40 gm protein

Intervention Type: DIETARY_SUPPLEMENT

Micronutrient

Dar-vite Multivitamin

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Dar-uji

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

C. Fordham von Reyn

Staff Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Charles F. von Reyn, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth College

Nyasule Majura-Neke, MD

Role: STUDY_DIRECTOR

Muhimbili University of Health and Allied Sciences

Locations

Infectious Disease Centre

Dar es Salaam, , Tanzania

Countries

Tanzania

References

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.

Reference Type: DERIVED

PMID: 35898141 (View on PubMed)

Other Identifiers

RO1 503498

Identifier Type: OTHER

Identifier Source: secondary_id

DarDar 2-C CPHS 21592 D12221

Identifier Type: -

Identifier Source: org_study_id