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A Comparison of Three Anti-HIV Drug Combinations Containing Saquinavir Soft Gelatin Capsules Used in HIV-1 Infected Patients

NCT00002378 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 825

Last updated 2005-06-24

No results posted yet for this 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.

Conditions

  • HIV Infections

Interventions

DRUG

Ritonavir

DRUG

Nelfinavir mesylate

DRUG

Saquinavir

DRUG

Delavirdine mesylate

DRUG

Lamivudine

DRUG

Stavudine

DRUG

Zidovudine

Sponsors & Collaborators

Study Design

Purpose
TREATMENT

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States
  • Germany
  • Italy
  • Puerto Rico
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00002378 on ClinicalTrials.gov