HIV, Tuberculosis
Conditions
Keywords
HIV, Tuberculosis, Nutrition
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).
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).
Interventions
DIETARY_SUPPLEMENTProtein calorie supplement
Fortified porridge with 1062 kcal and 40 gm protein
DIETARY_SUPPLEMENTMicronutrient
Dar-vite Multivitamin
Sponsors
National Institutes of Health (NIH)
Dartmouth-Hitchcock Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Protein-calorie supplement plus micronutrient vs micronutrient alone
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in CD4 Count | Baseline to 8 months | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BMI at 6 Months | baseline to 6 months | BMI will be compared between the two treatment groups |
| Number of Subjects Who Achieve 100 Cell Increase in CD4 | baseline to 8 months | Number of subjects in 2 treatment groups who achieve 100 cell increase in CD4 will be compared |
Countries
Tanzania
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Protein Calorie Supplement Plus Micronutrient Protein calorie supplement: Fortified porridge with 1062 kcal and 40 gm protein | 72 |
| Micronutrient Alone Micronutrient: Dar-vite Multivitamin | 79 |
| Total | 151 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 40 | 43 |
Baseline characteristics
| Characteristic | Micronutrient Alone | Protein Calorie Supplement Plus Micronutrient | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 79 Participants | 72 Participants | 151 Participants |
| Age, Continuous | 36 years | 37.5 years | 37 years |
| Region of Enrollment Tanzania | 79 participants | 72 participants | 151 participants |
| Sex: Female, Male Female | 79 Participants | 72 Participants | 151 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 72 | 0 / 79 |
| other Total, other adverse events | 0 / 72 | 0 / 79 |
| serious Total, serious adverse events | 0 / 72 | 0 / 79 |
Outcome results
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)
Time frame: Baseline to 8 months
Population: Women with newly diagnosed TB and newly diagnosed HIV, not on ART
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Protein Calorie Supplement Plus Micronutrient | Change in CD4 Count | 215 increase in CD4 cells/mm^3 | Standard Deviation 28 |
| Micronutrient Alone | Change in CD4 Count | 174 increase in CD4 cells/mm^3 | Standard Deviation 21 |
Secondary
BMI at 6 Months
BMI will be compared between the two treatment groups
Time frame: baseline to 6 months
Population: Women with newly diagnosed TB and newly diagnosed HIV not on ART
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Protein Calorie Supplement Plus Micronutrient | BMI at 6 Months | 25.4 kg/m^2 | Standard Deviation 5.73 |
| Micronutrient Alone | BMI at 6 Months | 24.7 kg/m^2 | Standard Deviation 4.99 |
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
Time frame: baseline to 8 months
Population: Women with newly diagnosed TB and newly diagnosed HIV not yet on ART
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Protein Calorie Supplement Plus Micronutrient | Number of Subjects Who Achieve 100 Cell Increase in CD4 | 25 N of subjects with CD4 increase of ≥100 |
| Micronutrient Alone | Number of Subjects Who Achieve 100 Cell Increase in CD4 | 26 N of subjects with CD4 increase of ≥100 |