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Glutatathione and whey protein
in HIV-AIDS
CTN
Trial Results
Whey
Protein for Wasting
CTN079:
Multicentre, Double-blind, Randomized Control Study of Whey Protein
Concentrate vs Casein in Patients with AIDS and Wasting Syndrome
Objective:
The purpose of the whey protein study was to determine whether
a whey protein concentrate (WPC) had an impact on the weight of
HIV patients suffering from wasting syndrome.
Study
Design: After a one-month screening period, volunteers
were randomized to Diet Regimen A (WPC) or Diet Regimen B (casein
- another milk product used as a control). Treatment continued
for six months. Researchers monitored weight gain to judge the
efficacy of the treatment.
Study
Population: Consenting, HIV-infected persons with at
least 10 % unintentional loss of body weight participated in this
study. They had a stable antiretroviral regimen and were free
of opportunistic infections and gastrointestinal disease for the
last six weeks at least.
This study
began at a time when many patients were beginning to receive the
benefits of protease inhibitors and wasting syndrome was becoming
uncommon. As a result, only 16 of the expected 60 participants
were recruited over a significant period of time and the study
was stopped.
Results:
Analysis of the results was done in case the magnitude of the
difference between groups was much larger than anticipated. In
fact, there was no significant difference in the weight gain between
the two groups of patients.
Conclusions:
The introduction of protease inhibitors drastically reduced the
number of patients with wasting syndrome and accounted for the
failure to meet the recruitment target. The limited number of
participants prevents a firm conclusion on the usefulness of HMS90TM
for wasting syndrome.
Note: These
results were taken from an abstract presented at the CAHR conference
2000.
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trials
database.
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