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NCT00002378 · ClinicalTrials.gov registry record · Phase 3
A Comparison of Three Anti-HIV Drug Combinations Containing Saquinavir Soft Gelatin Capsules Used in HIV-1 Infected Patients
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 825
- Enrollment target
NCT00002378 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 825 participants.
The verdict
NCT00002378, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 825 participants
- Enrollment target
Study Summary
To determine the proportion of patients whose plasma HIV-1 RNA level falls below the level of detection (\< 400 copies/ml) at week 24 of study therapy. To determine the absolute change in plasma HIV-1 RNA during the 24 weeks of study treatment. To collect safety data on the treatment regimens. AS PER AMENDMENT 12/12/97: To compare the virologic response of Fortovase (FTV) (Saquinavir) Soft Gel Capsule (SGC) tid plus nucleoside reverse transcriptase inhibitors (NRTIs) versus FTV bid plus NRTIs. Further, to compare the virologic response of FTV tid plus NRTIs versus FTV bid plus Nelfinavir bid plus a NRTI with respect to: the percentage of patients whose plasma HIV-1 RNA level falls below the Amplicor assay level of detection (\< 400 copies/ml) at week 24 and week 48.
Interventions
- DRUG Lamivudine
- DRUG Ritonavir
- DRUG Nelfinavir mesylate
- DRUG Delavirdine mesylate
- DRUG Saquinavir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 825 participants |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00002378
The ClinicalTrials.gov registry entry for NCT00002378 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 825 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Lamivudine is the first listed.
NCT00002378 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00002378 about?
NCT00002378 is a clinical study titled "A Comparison of Three Anti-HIV Drug Combinations Containing Saquinavir Soft Gelatin Capsules Used in HIV-1 Infected Patients". To determine the proportion of patients whose plasma HIV-1 RNA level falls below the level of detection (\< 400 copies/ml) at week 24 of study therapy. To determine the absolute change in plasma HIV-1 RNA during the 24 weeks of study treatment. To collect safety data on the treatment regimens. AS P...
What is the current status of trial NCT00002378?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 825 participants.
What interventions are being tested in trial NCT00002378?
The interventions under investigation include: Lamivudine (DRUG), Ritonavir (DRUG), Nelfinavir mesylate (DRUG), Delavirdine mesylate (DRUG), Saquinavir (DRUG).
Who is sponsoring clinical trial NCT00002378?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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