Search / Trial NCT00002425

The Safety and Effectiveness of Saquinavir Soft Gelatin Capsules Combined With Other Anti-HIV Drugs

Launched by HOFFMANN-LA ROCHE · Aug 30, 2001

Trial Information

Current as of November 03, 2024

Completed

Keywords

Drug Therapy, Combination Saquinavir Hiv Protease Inhibitors Dosage Forms Anti Hiv Agents

Description

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 w...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Antiretroviral treatments other than PIs.
  • Patients must have:
  • * HIV infection.
  • * No prior experience with PIs. (Note:
  • * At least 75 percent of patients must be naive to PIs.)
  • Exclusion Criteria
  • Concurrent Medication:
  • Excluded:
  • PIs other than SQV.
  • Prior Medication:
  • Excluded:
  • Any PIs (see note in General Criteria--Inclusion).

About Hoffmann La Roche

Hoffmann-La Roche, commonly known as Roche, is a global leader in biotechnology and pharmaceuticals, committed to advancing healthcare through innovative research and development. With a strong focus on oncology, immunology, infectious diseases, and central nervous system disorders, Roche leverages cutting-edge science to deliver transformative therapies and diagnostics. The company is dedicated to improving patient outcomes by conducting rigorous clinical trials and collaborating with healthcare professionals and organizations worldwide. Roche's unwavering commitment to precision medicine and personalized healthcare positions it at the forefront of the industry, driving progress in the quest for effective treatments and improved patient care.

Locations

Nutley, New Jersey, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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