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

Purpose

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).

Condition	Intervention	Phase
HIV Tuberculosis	Dietary Supplement: Protein calorie supplement Dietary Supplement: Micronutrient	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Randomized Controlled Trial of a Protein-calorie Supplement for HIV-infected Women With Tuberculosis

Resource links provided by NLM:

MedlinePlus related topics: Dietary Supplements HIV/AIDS Tuberculosis

Genetic and Rare Diseases Information Center resources: Tuberculosis

U.S. FDA Resources

Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:

Change in CD4 count [ Time Frame: Baseline to 8 months ]
We will calculate change in CD4 count from start of ART until 6 mos on ART

Secondary Outcome Measures:

BMI at 6 months [ Time Frame: baseline to 6 months ]
BMI will be compared between the two treatment groups
Proportion of subjects who achieve 100 cell increase in CD4 [ Time Frame: baseline to 8 months ]
% of subjects in 2 treatment groups who achieve 100 cell increase in CD4 will be compared


Enrollment:	151
Study Start Date:	May 2012
Study Completion Date:	July 2014
Primary Completion Date:	July 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Protein calorie supplement plus micronutrient	Dietary Supplement: Protein calorie supplement Fortified porridge with 1062 kcal and 40 gm protein Other Name: Dar-uji
Placebo Comparator: Micronutrient alone	Dietary Supplement: Micronutrient Dar-vite Multivitamin

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


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01635153

Locations


Tanzania
Infectious Disease Centre
Dar es Salaam, Tanzania

Sponsors and Collaborators

Dartmouth-Hitchcock Medical Center

National Institutes of Health (NIH)

Investigators


Principal Investigator:	Charles F. von Reyn, MD	Dartmouth College
Study Director:	Nyasule Majura-Neke, MD	Muhimbili University of Health and Allied Sciences

More Information


Responsible Party:	Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:	NCT01635153 History of Changes
Other Study ID Numbers:	DarDar 2-C CPHS 21592 RO1 503498 ( Other Identifier: NIH )
Study First Received:	May 23, 2012
Last Updated:	February 9, 2015

Keywords provided by Dartmouth-Hitchcock Medical Center:


HIV Tuberculosis Nutrition

Additional relevant MeSH terms:


Tuberculosis Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections	Micronutrients Trace Elements Growth Substances Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 22, 2017

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