Ignite Creation Date:
2024-05-06 @ 12:42 AM
Last Modification Date:
2024-10-26 @ 10:53 AM
Study NCT ID:
NCT01635153
Status:
COMPLETED
Last Update Posted:
2020-08-18
First Post:
2012-05-23
Brief Title:
Effects of a Protein Calorie Supplement in HIV-infected Women With Tuberculosis
Sponsor:
Dartmouth-Hitchcock Medical Center
Organization:
Dartmouth-Hitchcock Medical Center
Study Overview
Official Title:
Randomized Controlled Trial of a Protein-calorie Supplement for HIV-infected Women With Tuberculosis
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DarDar
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 ie 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 AZT3TCefavirenz The primary endpoint will be change in CD4 count after 8 months ie at end of PCSMNS intervention and 2 months after completion of ATT
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 ie 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 AZT3TCefavirenz The primary endpoint will be change in CD4 count after 8 months ie at end of PCSMNS intervention and 2 months after completion of ATT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RO1 503498 | OTHER | NIH | None |