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

May 23, 2012
January 29, 2014
May 2012
April 2014   (final data collection date for primary outcome measure)
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
Change in CD4 count [ Time Frame: Baseline to 8 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01635153 on ClinicalTrials.gov Archive Site
  • 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
  • BMI at 6 months [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]
  • Proportion of subjects who achieve 100 cell increase in CD4 [ Time Frame: baseline to 8 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effects of a Protein Calorie Supplement in HIV-infected Women With Tuberculosis
Randomized Controlled Trial of a Protein-calorie Supplement for HIV-infected Women With Tuberculosis

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).

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).

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV
  • Tuberculosis
  • Dietary Supplement: Protein calorie supplement
    Fortified porridge with 1062 kcal and 40 gm protein
    Other Name: Dar-uji
  • Dietary Supplement: Micronutrient
    Dar-vite Multivitamin
  • Active Comparator: Protein calorie supplement plus micronutrient
    Intervention: Dietary Supplement: Protein calorie supplement
  • Placebo Comparator: Micronutrient alone
    Intervention: Dietary Supplement: Micronutrient
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
180
April 2014
April 2014   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Tanzania
 
NCT01635153
DarDar 2-C CPHS 21592, RO1 503498
Yes
Dartmouth-Hitchcock Medical Center
Dartmouth-Hitchcock Medical Center
National Institutes of Health (NIH)
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
Dartmouth-Hitchcock Medical Center
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP