Search / Trial NCT00002374

A Study of Saquinavir Soft Gelatin Capsules Combined With Other Anti-HIV Drugs in HIV-1 Infected Patients

Launched by HOFFMANN-LA ROCHE · Aug 30, 2001

Trial Information

Current as of December 26, 2024

Completed

Keywords

Hiv 1 Drug Therapy, Combination Acquired Immunodeficiency Syndrome Hiv Protease Inhibitors Rna, Viral Saquinavir Anti Hiv Agents Viral Load

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Patients must have:
  • Documented HIV infection.
  • CD4 \> 100 cells/mm3.
  • Saquinavir HGC-experienced patients (\>= 3 months cumulative therapy).
  • Required:
  • \>= 3 months cumulative saquinavir HGC therapy.

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

Coral Gables, Florida, United States

Brookline, Massachusetts, United States

Beverly Hills, California, United States

Los Angeles, California, United States

Pittsburgh, Pennsylvania, United States

Tampa, Florida, United States

New York, New York, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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