Human Immunodeficiency Virus (HIV) Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT02511496 -
Status of Chronic Liver Disease in Hepatitis C Virus (HCV) Patients Coinfected With Human Immunodeficiency Virus (HIV) in Andalusia
|
N/A | |
| Completed |
NCT02234492 -
The Effects of Statin Therapy on Coronary Flow Reserve and Inflammatory Markers in HIV-Positive Patients
|
Phase 4 | |
| Completed |
NCT02027441 -
Enhanced Prevention in Couples: Feasibility Study #2
|
N/A | |
| Completed |
NCT01685372 -
Immunogenicity of Fluzone High Dose in Immunocompromised Children and Young Adults
|
Phase 2 | |
| Completed |
NCT02165202 -
Phase II Safety and Acceptability of an Investigational Injectable Product, TMC278LA, for Pre-Exposure Prophylaxis
|
Phase 2 | |
| Terminated |
NCT01448486 -
A Study of the Neurological Effects of Adding Raltegravir to HAART Regimen in Patients With HIV
|
Phase 4 | |
| Completed |
NCT01449006 -
A Study of the Neurological Effects of Adding Maraviroc to HAART Regimen in Patients With HIV (HANDmac)
|
Phase 4 | |
| Completed |
NCT02572401 -
Steering Together in a New Direction: Reducing the Risk of HIV/STD Among African American Men
|
N/A | |
| Completed |
NCT01615601 -
An Observational Study to Evaluate Tolerability of PREZISTA or INTELENCE in HIV-1 Infected Patients
|
Phase 4 | |
| Completed |
NCT04122404 -
POC Strategies to Improve TB Care in Advanced HIV Disease
|
N/A | |
| Completed |
NCT03290755 -
Sexual Hepatitis C in HIV Positive Men Who Have Sex With Men (MSM) in Bordeaux
|
||
| Completed |
NCT02974998 -
Cape Town Young Women's Health CoOp
|
N/A | |
| Completed |
NCT01516970 -
Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (PEP) With Darunavir/Ritonavir (DRV/r)
|
Phase 3 | |
| Completed |
NCT01997346 -
Multi-level Determinants of Starting ART Late: Aim 2
|
N/A | |
| Active, not recruiting |
NCT01875952 -
Diagnosis and Treatment of Co-infection With Human Immunodeficiency Virus /Latent Tuberculosis Infection (HIV/TBL)
|
Phase 4 | |
| Completed |
NCT01199939 -
A Study of the Once Daily Combination of Etravirine and Darunavir/Ritonavir As Dual Therapy in Early Treatment-Experienced Patients
|
Phase 2 | |
| Completed |
NCT03783130 -
Dose, Safety, Tolerability, and Immunogenicity of an HIV-1 Vaccine, VRC-HIVRGP096-00-VP, With Alum in Healthy Adults
|
Phase 1 | |
| Recruiting |
NCT05657106 -
Kentucky Outreach Service Kiosk (KyOSK): Reducing HIV, HCV, and Overdose Risk
|
N/A | |
| Not yet recruiting |
NCT05727033 -
Extraordinarily Fun Training Project in Compulsory Secondary Education - Sexually Transmitted Infections
|
N/A | |
| Completed |
NCT01053741 -
Effect of Seminal Fluid on the Colon Wall; Implications for HIV Transmission
|
N/A |