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

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ClinicalTrials.gov Identifier: NCT01635153
Recruitment Status : Completed
First Posted : July 9, 2012
Last Update Posted : February 10, 2015
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).

Condition or disease Intervention/treatment Phase
HIV Tuberculosis Dietary Supplement: Protein calorie supplement Dietary Supplement: Micronutrient Phase 2

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of a Protein-calorie Supplement for HIV-infected Women With Tuberculosis
Study Start Date : May 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. BMI at 6 months [ Time Frame: baseline to 6 months ]
    BMI will be compared between the two treatment groups

  2. 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


Eligibility Criteria
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 )
First Posted: July 9, 2012    Key Record Dates
Last Update Posted: February 10, 2015
Last Verified: February 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