Human Immunodeficiency Virus (HIV)Phase 3ININCT01171495
Impact of Nutrition Intervention on HIV/AIDS Infected Patients
A Phase 3 study testing Theragran-M; Ensure Plus and Theragran-M in people with Human Immunodeficiency Virus (HIV) and Acquired Immune Deficiency Syndrome (AIDS), run by Caribbean Health Research Council at 1 site in Jamaica.
Trial summary
Intervention to investigate the efficacy of a nutritional supplement among ARV-naïve, asymptomatic HIV positive patients with a CD4 count in the range 300-550 cells/ul. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Human Immunodeficiency Virus (HIV), Acquired Immune Deficiency Syndrome (AIDS)
- What is being tested?
- Theragran-M; Ensure Plus and Theragran-M
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteJamaica
- Study dates
- Apr 2008to Aug 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- HIV positive individuals in the age range 18 to 50 years.
- Individuals whose CD4 count was between 300-550 cells/uL.
- Individuals who met the study criteria and were interested in being enrolled.
- Individuals not on ARV therapy.
- Women who were not pregnant.
Who cannot join
- On the clinician's advice, individuals could be excluded from enrollment.
- Individuals who were unable to carry out the study intervention e.g. homeless, impaired mental state etc.
- Individuals who were unlikely to complete follow-up based on pre-enrolment assessment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 3 Study That Assesses the Impact of a Nutrition Intervention on HIV/AIDS Infected Patients: Kingston, Jamaica
Intervention to investigate the efficacy of a nutritional supplement among ARV-naïve, asymptomatic HIV positive patients with a CD4 count in the range 300-550 cells/ul.
Read the detailed description
To investigate the efficacy of a nutritional supplement among ARV-naïve, asymptomatic HIV positive patients with a CD4 count in the range 300-550 cells/ul.
A total of 120 participants will be stratified by age and gender and randomly assigned to two treatment arms. Sixty (60) participants will be assigned to receive dietary counselling and a multivitamin/mineral supplement, with sixty (60) additionally receiving an oral Medical Nutritional Supplement (MNS).
Participants will be followed for six months post-randomization: at baseline, 3 months and 6 months. The principal outcome measure is Body Mass Index, used as a proxy for 'nutritional status'. Secondary outcome measures include immune status and antioxidant status.
- Being tested
- Theragran-M; Ensure Plus, Theragran-M
- Keywords
- HIV/AIDS, Nutrition Therapy, Dietary Supplement, Antioxidant, Immunity, CD4 count, Anthropometry, Body Mass Index
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theragran-M; Ensure PlusDietary supplement
Theragran-M: One tablet daily for 6-months. Ensure Plus: One 8 fl.oz. bottle daily for 6-months. Nutritional counselling: at baseline, and at monthly follow-up visits.
Theragran-MDietary supplement
Theragran-M: One tablet daily for 6-months. Nutritional counselling: at baseline and at monthly follow-up visits.
| Study group | Role | What they receive |
|---|---|---|
| Ensure Plus + Multivitamin/Counselling | Experimental | Not described Receives: Dietary Supplement: Theragran-M; Ensure Plus |
| Multivitamin/Counselling | Active comparator | Not described Receives: Dietary Supplement: Theragran-M |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of nutritional intervention on anthropometry in HIV infected individuals.
Body Mass Index
Measured: 6 months
Secondary outcomes (1)
Effects of nutritional intervention on the clinical and immune status in HIV infected individuals.
Immune status (CD4 cell count, total lymphocyte count), antioxidant status.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2010 (estimated)
- Study startApr 2008
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency Virus (HIV)Studies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Caribbean Health Research Council
- Sponsor type
- University, hospital or other
- Collaborators
- The University of The West Indies
- Investigators
- Sharon M Dawson, MSc, Principal investigator, University of the West Indies, Mona ,Jamaica, West Indies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01171495
- Sponsor's protocol ID
- CHRC 51016
- Acronym
- INI
- Status last verified
- Feb 2010
- First submitted
- 27 Jul 2010
- Last updated
- 28 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study That Assesses the Impact of a Nutrition Intervention on HIV/AIDS Infected Patients: Kingston, Jamaica
- ClinicalTrials.gov ID
- NCT01171495
- Acronym / sponsor ID
- INI / CHRC 51016
- Keywords
- HIV/AIDS, Nutrition Therapy, Dietary Supplement, Antioxidant, Immunity, CD4 count, Anthropometry, Body Mass Index
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Caribbean Health Research CouncilUniversity, hospital or other
- Collaborators
- The University of The West Indies
- Study start
- Apr 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 28 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intervention to investigate the efficacy of a nutritional supplement among ARV-naïve, asymptomatic HIV positive patients with a CD4 count in the range 300-550 cells/ul.
Detailed description
To investigate the efficacy of a nutritional supplement among ARV-naïve, asymptomatic HIV positive patients with a CD4 count in the range 300-550 cells/ul.
A total of 120 participants will be stratified by age and gender and randomly assigned to two treatment arms. Sixty (60) participants will be assigned to receive dietary counselling and a multivitamin/mineral supplement, with sixty (60) additionally receiving an oral Medical Nutritional Supplement (MNS).
Participants will be followed for six months post-randomization: at baseline, 3 months and 6 months. The principal outcome measure is Body Mass Index, used as a proxy for 'nutritional status'. Secondary outcome measures include immune status and antioxidant status.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ensure Plus + Multivitamin/Counselling | Experimental | Dietary Supplement: Theragran-M; Ensure Plus |
| Multivitamin/Counselling | Active comparator | Dietary Supplement: Theragran-M |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- HIV positive individuals in the age range 18 to 50 years.
- Individuals whose CD4 count was between 300-550 cells/uL.
- Individuals who met the study criteria and were interested in being enrolled.
- Individuals not on ARV therapy.
- Women who were not pregnant.
Key exclusion criteria (3 listed)
- On the clinician's advice, individuals could be excluded from enrollment.
- Individuals who were unable to carry out the study intervention e.g. homeless, impaired mental state etc.
- Individuals who were unlikely to complete follow-up based on pre-enrolment assessment.
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 |
|---|---|---|
| Theragran-M; Ensure PlusTheragran-M: One tablet daily for 6-months. Ensure Plus: One 8 fl.oz. bottle daily for 6-months. Nutritional counselling: at baseline, and at monthly follow-up visits. | Dietary supplement | Ensure Plus + Multivitamin/Counselling |
| Theragran-MTheragran-M: One tablet daily for 6-months. Nutritional counselling: at baseline and at monthly follow-up visits. | Dietary supplement | Multivitamin/Counselling |
Primary outcome
Effects of nutritional intervention on anthropometry in HIV infected individuals.
Time frame: 6 months
Body Mass Index
1 secondary outcome
Effects of nutritional intervention on the clinical and immune status in HIV infected individuals.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2010.
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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.
Sharon M Dawson, MSc principal investigator
University of the West Indies, Mona ,Jamaica, West Indies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Theragran-M; Ensure Plus and Theragran-M in people with Human Immunodeficiency Virus (HIV) and Acquired Immune Deficiency Syndrome (AIDS), run by Caribbean Health Research Council at 1 site in Jamaica.
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 5 inclusion and 3 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 28 Jul 2010. 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 Jamaica. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effects of nutritional intervention on anthropometry in HIV infected individuals. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2010.