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No intervention; Observational study · 1 trial · 2 indications
| Name | Type | Description |
|---|---|---|
| No intervention; Observational study | DRUG | - |
Inclusion criteria: * Prior participation in study APV30005 AND one of the following studies: APV30001, APV30002, AZL30006, APV30003. * Must be failing virologically (\>1000 copies at two consecutive time-points) and have a screening genotype with evidence of at least one new APV-associated proteas...
It is a completed Phase 3 observational study that evaluated a protease inhibitor containing treatment regimen in people with HIV type I who had developed protease inhibitor mutations during earlier treatment with GW433908, also known as fosamprenavir. The study enrolled 20 participants and was conducted in the United States and Italy.
GSK plc, which trades under the ticker GSK, is the developer associated with this observational study of a protease inhibitor containing regimen in HIV. The study was conducted in the United States and Italy and has been completed.
The study is listed as Phase 3 and its status is completed. It was an observational study rather than a randomized or double-blind trial, and it was uncontrolled. It enrolled 20 participants aged 13 years and older, including all sexes, and did not include healthy volunteers.
The study is registered as NCT00242840, titled Observational Study Of A Protease Inhibitor (PI) Containing Regimen In Subjects With PI Mutations Selected During Prior Treatment With GW433908 (Fosamprenavir). It enrolled 20 participants across the United States and Italy and is listed as completed.
GW433908 is also known as fosamprenavir. It was the prior treatment referenced in the observational study, which examined a protease inhibitor containing regimen in subjects with protease inhibitor mutations selected during earlier treatment with GW433908. The study is registered as NCT00242840 and is completed.
The study evaluated infection with human immunodeficiency virus type I, also listed as HIV infection. It was an observational Phase 3 study of a protease inhibitor containing regimen in participants who had protease inhibitor mutations selected during prior treatment with GW433908, also known as fosamprenavir. Enrollment was 20 participants.