|
|
A
range of side-effects and abnormalities have been reported
since the introduction of HAART (Highly Active Retroviral
Therapy). One of these is Human Immuno-deficiency Virus-Associated
Adipose Redistribution Syndrome (HARS). The key feature
of HARS is abnormal accumulation of internal abdominal
fat, and may also involve abnormal fat accumulation in
other areas: back of the neck, mammary/pectoral, lipomas
(tumor-like fatty deposits) and other areas. |
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Objective
|
To
see if Serostim™ reduces the maldistribution of fat
tissue associated with HARS and improve quality of life
of volunteers with HARS. |
|
|
Individual
doses of Serostim™ will be determined by body weight.
This is a Phase II/III multi-center, double-blind, randomized,
parallel-group, placebo-controlled dose-finding trial
of Serostim™ vs. placebo in volunteers with HARS.
|
|
Inclusion
Criteria
|
partial
list:
•
HIV+ male or female at least 18-60 years old.
•
Excess abdominal adipose deposition
•
On stable antiretroviral medication(s)
•
Viral load greater or equal to than 1000 copies/mL.
•
If female, non-breastfeeding and practicing contraception.
|
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Status
__
|
Enrollment complete, study ongoing
--
|
For
more information about participating in this study
in the Los Angeles area, please call 310/358.2429
or e-mail Corie Castro at ccastro@aidsresearch.org
|
|
We
encourage participation by women and people of color.
This
ad was reviewed and approved by the AIDS Research Alliance
Institutional Review Board in April, 2001.
|
