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| Name | Class |
|---|---|
| The University of The West Indies | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ensure Plus + Multivitamin/Counselling | Experimental |
| |
| Multivitamin/Counselling | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Theragran-M; Ensure Plus | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of nutritional intervention on anthropometry in HIV infected individuals. | Body Mass Index | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of nutritional intervention on the clinical and immune status in HIV infected individuals. | Immune status (CD4 cell count, total lymphocyte count), antioxidant status. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon M Dawson, MSc | University of the West Indies, Mona ,Jamaica, West Indies | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Health Centre | Kingston | Jamaica |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C047053 | Theragran-M |
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| Theragran-M | Dietary Supplement | Theragran-M: One tablet daily for 6-months. Nutritional counselling: at baseline and at monthly follow-up visits. |
|
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |