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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01635153
First received: May 23, 2012
Last updated: January 29, 2014
Last verified: January 2014
  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
Endpoint Classification: Efficacy Study
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:


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

Primary Outcome Measures:
  • Change in CD4 count [ Time Frame: Baseline to 8 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    % of subjects in 2 treatment groups who achieve 100 cell increase in CD4 will be compared


Estimated Enrollment: 180
Study Start Date: May 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 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
Genders 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
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
Investigators
Principal Investigator: Charles F. von Reyn, MD Geisel School of Medicine at Dartmouth
Study Director: Nyasule Majura-Neke, MD Muhimbili University of Health and Allied Sciences
  More Information

No publications provided

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01635153     History of Changes
Other Study ID Numbers: DarDar 2-C CPHS 21592, RO1 503498
Study First Received: May 23, 2012
Last Updated: January 29, 2014
Health Authority: Tanzania:Research Ethics Committee, MUHAS

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014