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

HIV Clinical Trial

— DarDar  

Official title:

Randomized Controlled Trial of a Protein-calorie Supplement for HIV-infected Women With Tuberculosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01635153
• Other study ID #: DarDar 2-C CPHS 21592 D12221
• Secondary ID: RO1 503498
• Status: Completed
• Phase: N/A
• Start date: May 2012
• Est. completion date: July 2014

Study information

• Verified date: August 2020
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV
• Tuberculosis

Intervention

Dietary Supplement:
• Protein calorie supplement
Fortified porridge with 1062 kcal and 40 gm protein
• Micronutrient
Dar-vite Multivitamin

Locations

Country	Name	City	State
Tanzania	Infectious Disease Centre	Dar es Salaam

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	National Institutes of Health (NIH)

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in CD4 Count	We will calculate change in CD4 count from start of ART until 6 mos on ART (which is started 2 mos after study enrollment, hence 8 mos after enrollment)	Baseline to 8 months
Secondary	BMI at 6 Months	BMI will be compared between the two treatment groups	baseline to 6 months
Secondary	Number of Subjects Who Achieve 100 Cell Increase in CD4	Number of subjects in 2 treatment groups who achieve 100 cell increase in CD4 will be compared	baseline to 8 months