Status:
COMPLETED
A Study to Compare Two Anti-HIV Combination Therapies Each Containing Saquinavir in HIV-Positive Children
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
3-16 years
Phase:
PHASE2
Brief Summary
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 dr...
Detailed 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 o...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
April 1 2001
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00000913
End Date
April 1 2001
Last Update
October 29 2021
Active Locations (36)
Enter a location and click search to find clinical trials sorted by distance.
1
Univ of Alabama at Birmingham / Childrens Hosp of AL
Birmingham, Alabama, United States, 352330011
2
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, United States, 35233
3
Long Beach Memorial (Pediatric)
Long Beach, California, United States, 90801
4
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033