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

Completed · Phase 2

Conditions studied: HIV Infections

In brief

The purpose of this study is to determine the safety and effectiveness of a soft-gel capsule formulation of saquinavir (SQV-SGC), a protease inhibitor, when given in combination with other anti-HIV drugs. SQV-SGC has been tested in adults for the treatment of HIV infection, but more information is still needed about SQV-SGC in children. Recent studies suggest that this soft-gel capsule form may be safer and more effective than other protease inhibitors.

Key facts

Study ID

NCT00000913

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

50

Expected to finish

2001-04-01

Last updated by the study team

2021-10-29

Who can join

Age: 3 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Univ of Alabama at Birmingham / Childrens Hosp of AL — Birmingham, Alabama, United States
• Univ of Alabama at Birmingham - Pediatric — Birmingham, Alabama, United States
• Long Beach Memorial (Pediatric) — Long Beach, California, United States
• Los Angeles County - USC Med Ctr — Los Angeles, California, United States
• Children's Hosp of Oakland — Oakland, California, United States
• UCSF / Moffitt Hosp - Pediatric — San Francisco, California, United States
• Yale Univ Med School — New Haven, Connecticut, United States
• Howard Univ Hosp — Washington D.C., District of Columbia, United States
• Univ of Miami (Pediatric) — Miami, Florida, United States
• Palm Beach County Health Dept — Riviera Beach, Florida, United States
• Emory Univ Hosp / Pediatrics — Atlanta, Georgia, United States
• Cook County Hosp — Chicago, Illinois, United States
• Univ of Illinois College of Medicine / Pediatrics — Chicago, Illinois, United States
• Chicago Children's Memorial Hosp — Chicago, Illinois, United States
• Tulane Univ / Charity Hosp of New Orleans — New Orleans, Louisiana, United States
• Univ of Maryland at Baltimore / Univ Med Ctr — Baltimore, Maryland, United States
• Children's Hosp of Boston — Boston, Massachusetts, United States
• Baystate Med Ctr of Springfield — Springfield, Massachusetts, United States
• Univ of Mississippi Med Ctr — Jackson, Mississippi, United States
• Univ of Medicine & Dentistry of New Jersey / Univ Hosp — Newark, New Jersey, United States
• Children's Hosp at Albany Med Ctr — Albany, New York, United States
• North Shore Univ Hosp — Great Neck, New York, United States
• Cornell Univ Med College — New York, New York, United States
• Columbia Presbyterian Med Ctr — New York, New York, United States
• Incarnation Children's Ctr / Columbia Presbyterian Med Ctr — New York, New York, United States

Full record on ClinicalTrials.gov

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