Clinical trial to be performed in Mulago Hospital in Kampala, Uganda:
Study Design:
The objective of this clinical study is to assess, under controlled conditions, the effect of Myogence on specific HIV/AIDS patient groups, who are already undergoing ART treatment, to determine the nature and extent of various anticipated beneficial outcomes.
This Phase II human study will be a randomized, double-blind study comparing the efficacy of Myogence against that of placebo in patients age 18 years or over, as a supplement to afford greater energy, nutritional enhancement, and recovery to patients under anti-retroviral treatment (ART) for HIV/AIDS.
The lethargy, loss of energy and metabolic challenges of such necessary treatments often render therapeutic regimen adherence very problematic, even amidst a demand for adherence significantly higher than for many other disease treatments (one with negative epidemiological consequences, and thus with major treatment policy and global health consequences which translate into costs as it complicates the treatment screening process).
These negative effects on the patient also add to national economic costs, as productivity is diminished. Positive trial outcomes will, thus, address very real personal and national health, economic and political problems, especially in Sub Saharan Africa.
Outcome Measures
1. Primary outcome measures
- Increased energy and quality of life of HIV/AIDS patients
- Improved regimen adherence among HIV/AIDS patients
- Improved gastrointestinal absorption of nutrients
- Improved nutritional status of HIV/AIDS patients
2. Secondary outcome measures
- Improved general health status
- Reduced severity and aggressiveness of HIV/AIDS over and above ART alone
- Improved immunocompetence to augment natural defense mechanisms against HIV/AIDS and other secondarily associated lethal infections including tuberculosis, fungal infections, etc.