A Phase 3 interventional study of Ritonavir and Nelfinavir mesylate in HIV Infections, sponsored by Hoffmann-La Roche. Completed at 7 sites in United States. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
To examine the efficacy of saquinavir SGC (soft gel capsules) in combination with other antiretrovirals in HIV-1 infected patients currently treated with saquinavir HGC (hard gel capsules) measured by the absolute change in plasma HIV-1 RNA during the 24 weeks of study treatment.
Eligible patients will be stratified by HIV-1 RNA level into 2 populations: 1) >= 5,000-30,000 HIV-1 RNA, 2) > 30,000 HIV-1 RNA. All patients will be randomized to 1 of 3 treatment arms: Arm A - Saquinavir soft gel capsules (SQV SGC) + 2 new nucleoside analogs (reverse transcriptase inhibitors [RTIs]), Arm B - SQV SGC + nelfinavir + stavudine (d4T) or a new RTI, or Arm C - SQV SGC + ritonavir + d4T or a new RTI. All patients will undergo plasma HIV-1 RNA determinations, CD4 lymphocyte counts, hematology and chemistry blood work at baseline, weeks 4, 8, 12, 16 and 24.
6,686 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 120 is close to the median of 120 across 4,199 interventional studies indexed under Infections.
Browse 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.
Inclusion Criteria
Patients must have:
Required:
>= 3 months cumulative saquinavir HGC therapy.
This study is completed, as verified in Aug 1997. You cannot join it, but the record below documents what was studied.
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