Search / Trial NCT00002229

Safety and Effectiveness of Adding Saquinavir (FORTOVASE) in Soft Gel Capsule Form to an Anti-HIV Drug Combination in HIV-Infected Patients

Launched by HOFFMANN-LA ROCHE · Aug 30, 2001

Trial Information

Current as of December 26, 2024

Completed

Keywords

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

ClinConnect Summary

Prior to initiation of study treatment all patients are screened and baseline lab values are taken. Patients then receive the study treatment, FORTOVASE, two times a day plus 2 new NRTI's. Assessments will be performed at specified intervals throughout the duration of treatment.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • You may be eligible for this study if you:
  • Are HIV-positive.
  • Have an HIV count of 5,000 copies/ml or more.
  • Have a CD4 count of 100 cells/mm3 or more.
  • Meet specific requirements if you have ever taken NRTIs.
  • Are 16 - 64 years old (need consent if under 18).
  • Agree to use effective methods of birth control during the study.
  • Exclusion Criteria
  • You will not be eligible for this study if you:
  • Have taken non-nucleoside reverse transcriptase inhibitors (NNRTIs) or protease inhibitors (PIs) for more than 2 weeks.
  • Have taken all the available NRTIs.
  • Have certain serious medical conditions, including severe liver disease or active opportunistic (AIDS-related) infection.
  • Have a history of weight loss, muscle pain, and loss of appetite.
  • Have taken certain medications, including anti-HIV drugs other than those required by this study.
  • Are pregnant or breast-feeding.
  • Abuse alcohol or drugs.
  • Are unable to complete the study for any reason.

Trial Officials

S Palleja

Study Chair

C Karol

Study Chair

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

New York, New York, United States

Chicago, Illinois, United States

Pawtucket, Rhode Island, United States

Charlottesville, Virginia, United States

Washington, District Of Columbia, United States

Hobson City, Alabama, United States

Phoenix, Arizona, United States

Paramount, California, United States

Jacksonville, Florida, United States

Tampa, Florida, United States

Decatur, Georgia, United States

Lexington, Kentucky, United States

New Orleans, Louisiana, United States

Newark, New Jersey, United States

Newark, New Jersey, United States

Brooklyn, New York, United States

Brooklyn, New York, United States

Mt. Vernon, New York, United States

New York, New York, United States

Houston, Texas, United States

Vancouver, British Columbia, Canada

San Turce, , Puerto Rico

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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