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
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
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 September 11, 2014