Status:
COMPLETED
A Study of Invirase (Saquinavir)/Ritonavir in HIV-Infected Infants and Children.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
HIV Infections
Eligibility:
All Genders
4-6 years
Phase:
PHASE2
Brief Summary
This single arm study will assess the pharmacokinetics, safety and activity of saquinavir (Invirase hard gel capsules, film coated tablets or opened capsules) boosted by combination with ritonavir, in...
Eligibility Criteria
Inclusion
- infants and children, 4 months to \<6 years;
- confirmed HIV-1 infection;
- patients for whom saquinavir/ritonavir together with \>=2 background ARVs is considered appropriate.
Exclusion
- body weight \>4kg/8.8 pounds;
- use of any concomitant medications that may interfere with the pharmacokinetics of saquinavir or ritonavir;
- malabsorption, severe chronic diarrhea or vomiting within 28 days of the study.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00623597
Start Date
June 1 2008
End Date
March 1 2010
Last Update
March 7 2016
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Buenos Aires, Argentina, 1202
2
Buenos Aires, Argentina, 1425
3
Santa Fe, Argentina, 3000
4
Madrid, Madrid, Spain, 28046