Search / Trial NCT00000913

A Study to Compare Two Anti-HIV Combination Therapies Each Containing Saquinavir in HIV-Positive Children

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of September 11, 2024

Completed

Keywords

Saquinavir Reverse Transcriptase Inhibitors Anti Hiv Agents Viral Load

Description

Clinical trials in adults and children suggest that SQV-SGC has advantages over other protease inhibitors in terms of tolerability, safety, and effectiveness in patients who have failed therapy with other protease inhibitors. \[AS PER AMENDMENT 11/24/99: Pharmacokinetic data from this study demonstrate lower than expected plasma SQV exposures, particularly in Arm 1. Based on these data, patients in the study will be offered the opportunity to adjust their doses. Ritonavir added to the Arm 1 regimen is expected to significantly increase SQV-SGC plasma levels and allow twice-daily dosing for ...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Your child may be eligible for this study if he or she:
  • * Is HIV-positive.
  • * Is 3 to 16 years of age (consent of parent or guardian is required).
  • * Has an HIV level greater than 10,000 copies/ml.
  • * Has never taken at least one of the following anti-HIV drugs: lamivudine, zidovudine, stavudine, or didanosine.
  • * Is able to swallow capsules and tablets.
  • Exclusion Criteria
  • Your child will not be eligible if he or she:
  • * Has cancer requiring chemotherapy.
  • * Has an acute opportunistic (AIDS-related) infection requiring therapy.
  • * Has had two or more episodes of moderate or severe diarrhea or vomiting in the 3 months prior to study entry.
  • * Has ever taken SQV or NFV.
  • * Is pregnant or breast-feeding.
  • * Is taking certain medications, including those that would interfere with the study drugs.

About Sponsor

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Los Angeles, California, United States

Springfield, Massachusetts, United States

Seattle, Washington, United States

Bronx, New York, United States

Long Beach, California, United States

Oakland, California, United States

San Francisco, California, United States

New Haven, Connecticut, United States

Washington, District Of Columbia, United States

Miami, Florida, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Albany, New York, United States

Great Neck, 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

Stony Brook, New York, United States

Philadelphia, Pennsylvania, United States

Charleston, South Carolina, United States

Bayamon, , Puerto Rico

San Juan, , Puerto Rico

San Juan, , Puerto Rico

Newark, New Jersey, United States

Bronx, New York, United States

New Orleans, Louisiana, United States

Birmingham, Alabama, United States

Riviera Beach, Florida, United States

Jackson, Mississippi, United States

Richmond, Virginia, United States

Birmingham, Alabama, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0