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| ID | Type | Description | Link |
|---|---|---|---|
| RO1 503498 | Other Identifier | NIH |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Protein calorie supplement plus micronutrient | Active Comparator |
| |
| Micronutrient alone | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protein calorie supplement | Dietary Supplement | Fortified porridge with 1062 kcal and 40 gm protein |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| BMI at 6 Months | BMI will be compared between the two treatment groups | baseline to 6 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles F. von Reyn, MD | Dartmouth College | Principal Investigator |
| Nyasule Majura-Neke, MD | Muhimbili University of Health and Allied Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Infectious Disease Centre | Dar es Salaam | Tanzania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35898141 | Derived | Magohe A, Kimario J, Lukmanji Z, Hendricks K, Koethe JR, Neke NM, Tvaroha S, Connor R, Mackenzie T, Waddell R, Maro I, Matee M, Pallangyo K, Bakari M, Horsburgh CR, von Reyn CF. Randomized, controlled trial of a protein-calorie supplement for women coinfected with HIV-TB. Int J Tuberc Lung Dis. 2022 Aug 1;26(8):798-800. doi: 10.5588/ijtld.21.0669. No abstract available. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Protein Calorie Supplement Plus Micronutrient | Protein calorie supplement: Fortified porridge with 1062 kcal and 40 gm protein |
| FG001 | Micronutrient Alone | Micronutrient: Dar-vite Multivitamin |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Non-malnourished women with newly diagnosed TB and newly diagnosed HIV, not on ART at time of enrollment
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| ID | Title | Description |
|---|---|---|
| BG000 | Protein Calorie Supplement Plus Micronutrient | Protein calorie supplement: Fortified porridge with 1062 kcal and 40 gm protein |
| BG001 | Micronutrient Alone | Micronutrient: Dar-vite Multivitamin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Women with newly diagnosed TB and newly diagnosed HIV, not on ART | Posted | Mean | Standard Deviation | increase in CD4 cells/mm^3 | Baseline to 8 months |
|
8 months
Standard definitions
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Protein Calorie Supplement Plus Micronutrient | Protein calorie supplement: Fortified porridge with 1062 kcal and 40 gm protein |
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Many patients were lost to follow-up which may interfere with the evaluation of treatment effects
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr C Fordham von Reyn | Dartmouth-Hitchcock | 6036507167 | fvr@dartmouth.edu |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| D018977 | Micronutrients |
| ID | Term |
|---|---|
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000078622 | Nutrients |
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Protein-calorie supplement plus micronutrient vs micronutrient alone
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| Micronutrient | Dietary Supplement | Dar-vite Multivitamin |
|
| baseline to 8 months |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
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| Secondary | BMI at 6 Months | BMI will be compared between the two treatment groups | Women with newly diagnosed TB and newly diagnosed HIV not on ART | Posted | Mean | Standard Deviation | kg/m^2 | baseline to 6 months |
|
|
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| 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 | Women with newly diagnosed TB and newly diagnosed HIV not yet on ART | Posted | Number | N of subjects with CD4 increase of ≥100 | baseline to 8 months |
|
|
|
| 0 |
| 72 |
| 0 |
| 72 |
| 0 |
| 72 |
| EG001 | Micronutrient Alone | Micronutrient: Dar-vite Multivitamin | 0 | 79 | 0 | 79 | 0 | 79 |
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| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |