HIVDarDarNCT01635153
Effects of a Protein Calorie Supplement in HIV-infected Women With Tuberculosis
A study testing Protein calorie supplement and Micronutrient in people with HIV and Tuberculosis, run by Dartmouth-Hitchcock Medical Center at 1 site in Tanzania.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV, Tuberculosis
- What is being tested?
- Protein calorie supplement and Micronutrient
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 151 participants
- Where
- 1 siteTanzania
- Study dates
- May 2012to Jul 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female,
- HIV,
- age > 18,
- CD4 > 50,
- BMI>16
- new TB diagnosis,
- not on anti-retroviral therapy,
- residence in Dar es Salaam
Who cannot join
- current anti-retroviral therapy,
- serious co-morbidities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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).
- Conditions
- HIV, Tuberculosis
- Being tested
- Protein calorie supplement, Micronutrient
- Keywords
- HIV, Tuberculosis, Nutrition
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein calorie supplementDietary supplement
Also called Dar-uji
Fortified porridge with 1062 kcal and 40 gm protein
MicronutrientDietary supplement
Dar-vite Multivitamin
| Study group | Role | What they receive |
|---|---|---|
| Protein calorie supplement plus micronutrient | Active comparator | Not described Receives: Dietary Supplement: Protein calorie supplement |
| Micronutrient alone | Placebo comparator | Not described Receives: Dietary Supplement: Micronutrient |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline to 8 months
Secondary outcomes (2)
BMI at 6 Months
BMI will be compared between the two treatment groups
Measured: 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
Measured: baseline to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2012 (estimated)
- Study startMay 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Protein-calorie supplement plus micronutrient vs micronutrient alone
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, C. Fordham von Reyn, Dartmouth-Hitchcock Medical Center
- Investigators
- Charles F. von Reyn, MD, Principal investigator, Dartmouth CollegeNyasule Majura-Neke, MD, Study director, Muhimbili University of Health and Allied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01635153
- Sponsor's protocol ID
- DarDar 2-C CPHS 21592 D12221
- Other IDs
- RO1 503498
- Acronym
- DarDar
- Status last verified
- Aug 2020
- First submitted
- 23 May 2012
- Last updated
- 18 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35898141
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of a Protein-calorie Supplement for HIV-infected Women With Tuberculosis
- ClinicalTrials.gov ID
- NCT01635153
- Acronym / sponsor ID
- DarDar / DarDar 2-C CPHS 21592 D12221
- Conditions
- HIV, Tuberculosis
- Keywords
- HIV, Tuberculosis, Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- May 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 9 Jul 2012 (estimated)
- Results
- Posted 18 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Protein-calorie supplement plus micronutrient vs micronutrient alone
| Arm | Type | Receives |
|---|---|---|
| Protein calorie supplement plus micronutrient | Active comparator | Dietary Supplement: Protein calorie supplement |
| Micronutrient alone | Placebo comparator | Dietary Supplement: Micronutrient |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- female,
- HIV,
- age > 18,
- CD4 > 50,
- BMI>16
Key exclusion criteria (2 listed)
- current anti-retroviral therapy,
- serious co-morbidities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protein calorie supplementAlso: Dar-ujiFortified porridge with 1062 kcal and 40 gm protein | Dietary supplement | Protein calorie supplement plus micronutrient |
| MicronutrientDar-vite Multivitamin | Dietary supplement | Micronutrient alone |
Primary outcome
Change in CD4 Count
Time frame: 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)
2 secondary outcomes
BMI at 6 Months
Time frame: baseline to 6 months
Number of Subjects Who Achieve 100 Cell Increase in CD4
Time frame: baseline to 8 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35898141Magohe 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles F. von Reyn, MD principal investigator
Dartmouth College
Nyasule Majura-Neke, MD study director
Muhimbili University of Health and Allied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein calorie supplement and Micronutrient in people with HIV and Tuberculosis, run by Dartmouth-Hitchcock Medical Center at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CD4 Count (time frame: Baseline to 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01635153, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2020.