Search / Trial NCT00002378

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

Launched by HOFFMANN-LA ROCHE · Aug 30, 2001

Trial Information

Current as of December 06, 2024

Completed

Keywords

Hiv 1 Drug Therapy, Combination Zidovudine Stavudine Hiv Protease Inhibitors Lamivudine Rna, Viral Dosage Forms Saquinavir Reverse Transcriptase Inhibitors Anti Hiv Agents Viral Load Nelfinavir

ClinConnect Summary

Patients will be randomized to receive 1 of 3 study regimens: Group A - Saquinavir (SQV) sgc plus 2 new reverse transcriptase inhibitors (RTIs), Group B - SQV sgc plus delavirdine plus new RTI, and Group C - SQV sgc plus nelfinavir plus new RTI, or SQV sgc plus ritonavir plus 2 new RTIs.

NOTE: "New RTI" is defined for this study as any reverse transcriptase inhibitor to which the patient has never been exposed.

AS PER AMENDMENT 12/12/97: In this open-label, multicenter, Phase IIIB, comparative study, 825 patients are randomized to treatment arms. (NOTE: 50% of the patients will be treatme...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Patients must have:
  • HIV-1 infection.
  • HIV RNA \>= 5000 copies/ml by Amplicor assay.
  • Signed, informed consent from parent or legal guardian for patients less than 18 years old.
  • Prior Medication:
  • Required:
  • (Note:
  • 50% of the patients will be treatment naive).
  • \> 3 months cumulative therapy with antiretrovirals other than non-nucleoside reverse transcriptase inhibitors and/or protease inhibitors.
  • Stable antiretroviral therapy for at least 4 weeks prior to enrollment.
  • Allowed:
  • \<= 2 weeks cumulative treatment with protease inhibitors.
  • AS PER AMENDMENT 12/12/97:
  • Required:
  • NRTI experienced patients:
  • \> 3 months cumulative therapy with antiretrovirals.
  • \<= 2 weeks cumulative previous treatment with non-nucleoside analogue reverse transcriptase inhibitors (NNRTIs).
  • \<= 2 weeks cumulative previous treatment with protease inhibitors.
  • Must have at least one NRTI (preferably two) to which he/she has not been previously exposed.
  • * Stable antiretroviral therapy defined as within (+/-) 1 log HIV-1 RNA between the 2 most recent values greater than 8 weeks apart (may include screening visit) prior to study enrollment. (NOTE:
  • If patient does not have a previous HIV-1 RNA value, screening will be accepted.)
  • Required:
  • * Note:
  • 50% of the patients will be treatment naive and 50% will be NRTI experienced. AS PER AMENDMENT 12/12/97.

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

Rochester, Minnesota, United States

New York, New York, United States

Atlanta, Georgia, United States

Worcester, Massachusetts, United States

New York, New York, United States

Washington, District Of Columbia, United States

Albany, New York, United States

East Meadow, New York, United States

Manhasset, New York, United States

San Francisco, California, United States

San Juan, , Puerto Rico

Tampa, Florida, United States

Annandale, Virginia, United States

Dallas, Texas, United States

Houston, Texas, United States

Redwood City, California, United States

Detroit, Michigan, United States

San Rafael, California, United States

Newark, New Jersey, United States

New York, New York, United States

New York, New York, United States

San Francisco, California, United States

Camden, New Jersey, United States

Tampa, Florida, United States

Denver, Colorado, United States

Providence, Rhode Island, United States

Kansas City, Missouri, United States

Charlotte, North Carolina, United States

Tarzana, California, United States

Los Angeles, California, United States

Fort Lauderdale, Florida, United States

Chicago, Illinois, United States

Austin, Texas, United States

Bronx, New York, United States

Kansas City, Missouri, United States

Washington, District Of Columbia, United States

Los Angeles, California, United States

Brookline, Massachusetts, United States

Dallas, Texas, United States

Tucson, Arizona, United States

Altamonte Springs, Florida, United States

Fort Myers, Florida, United States

Vero Beach, Florida, United States

Philadelphia, Pennsylvania, United States

San Francisco, California, United States

Tampa, Florida, United States

Brooklyn, New York, United States

Mt. Vernon, New York, United States

New York, New York, United States

New York, New York, United States

Columbia, South Carolina, United States

Greenville, North Carolina, United States

Winston Salem, North Carolina, United States

Buffalo, New York, United States

Las Vegas, Nevada, United States

Indianapolis, Indiana, United States

Minneapolis, Minnesota, United States

Cincinnati, Ohio, United States

Houston, Texas, United States

Los Angeles, California, United States

Aniston, Alabama, United States

Phoenix, Arizona, United States

Tucson, Arizona, United States

Berkeley, California, United States

Irving, California, United States

North Hollywood, California, United States

Paramount, California, United States

San Francisco, California, United States

Denver, Colorado, United States

Washington, District Of Columbia, United States

Fort Lauderdale, Florida, United States

Jacksonville, Florida, United States

Miami, Florida, United States

Palm Beach Gardens, Florida, United States

Decatur, Georgia, United States

Springfield, Illinois, United States

Urbana, Illinois, United States

Lexington, Kentucky, United States

Ypsilanti, Michigan, United States

Lebanon, New Hampshire, United States

East Orange, New Jersey, United States

Paterson, New Jersey, United States

Elmhurst, New York, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

Charlotte, North Carolina, United States

Oklahoma City, Oklahoma, United States

Allentown, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Dallas, Texas, United States

Houston, Texas, United States

Seattle, Washington, United States

Milwaukee, Wisconsin, United States

Duesseldorf, , Germany

Milano, , Italy

Barcelona, , Spain

Liverpool, , United Kingdom

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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