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Tipranavir
belongs to a new class of protease inhibitor and has been
shown to suppress multiply drug resistant HIV in previous
test tube studies.
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Objective
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To
evaluate the safety and effectiveness of two different
doses of Tipranavir taken with Ritonavir as compared with
the standard combination of Saquinavir and Ritonavir.
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A
Phase II, open-label, randomized study. The study will
last 24 weeks and there is an optional 24-week extension
phase. There is no placebo group in this study–all
participants will receive combination therapy. Participants
will be assigned to one of three study groups:
- Group
1 will receive Tipranavir with Ritonavir and 2 nucleoside
reverse transcriptase inhibitors (NRTIs).
- Group
2 will receive a higher dose of Tipranavir, Ritonavir
and 2 NRTIs.
- Group
3 will receive Saquinivir, Ritonavir and 2 NRTIs.
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Inclusion
Criteria
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- Failing
first protease inhibitor (either Crixivan, Viracept
or Amprenavir).
- HIV+
man or woman, at least 18 years old.
- Viral
load greater than or equal to 5,000 copies.
- T-cell
count greater than or equal to 50.
- Cannot
have ever taken more than 5 different NRTIs.
- Women
who are not pregnant and are willing to use contraceptives
for the duration of the study.
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Status
__
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Enrolling
--
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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
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We encourage
participation by women and people of color.
This
ad was reviewed and approved by the AIDS Research
Alliance Institutional Review Board on August 15,
2000.
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