A Phase 4 interventional study of Saquinavir in HIV Infections, sponsored by Hoffmann-La Roche. Completed at 1 site in United States. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.
Sponsored by Hoffmann-La Roche · Phase 4, Interventional, and Treatment
To evaluate the safety and antiretroviral activity of saquinavir soft gelatin capsule formulation (SQV-SGC) in combination with other antiretroviral drugs.
All patients receive SQV as monotherapy or in combination with other antiretroviral drugs chosen by the investigator and patient. (This study provides only SQV.) Patients may not choose another protease inhibitor (PI) as part of their combination therapy; furthermore, patients taking PIs other than SQV must undergo a 5-day washout period before study-drug administration. Patients are monitored for adverse events and changes in routine laboratory tests, plasma viral load, and CD4+ T cell levels. Outcomes are analyzed by stratifying patients according to CD4+ T cell levels and prior history with protease inhibitors.
4,257 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 400 is above the median of 83 across 3,250 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Concurrent Medication:
Allowed:
Antiretroviral treatments other than PIs.
Patients must have:
Exclusion Criteria
Concurrent Medication:
Excluded:
PIs other than SQV.
Prior Medication:
Excluded:
Any PIs (see note in General Criteria--Inclusion).
This study is completed, as verified in Dec 1996. You cannot join it, but the record below documents what was studied.
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Hoffmann-La Roche