Who is sponsoring NCT00084058?

NCT00084058 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

What condition does NCT00084058 study?

NCT00084058 studies HIV Infections.

What drugs are being tested in NCT00084058?

Interventions: Lopinavir/ritonavir, Saquinavir.

What is the status of NCT00084058?

NCT00084058 is currently COMPLETED.

Last reviewed 2021-10-28 · How we verify

A Phase I/II Safety, Tolerability, and Pharmacokinetic Study of High Dose Lopinavir/Ritonavir With or Without Saquinavir in HIV-Infected Pediatric Subjects Previously Treated With Protease Inhibitors

NCT00084058 Phase 1/Phase 2 COMPLETED

The purpose of this study is to determine the effect of increased doses of lopinavir/ritonavir (LPV/r) and saquinavir (SQV) in HIV infected children who are failing their current antiretroviral regimen

Details

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	26
Completion	2006-12

Conditions

HIV Infections

Interventions

Lopinavir/ritonavir
Saquinavir

Primary outcomes

Life-threatening adverse events attributable to study drugs
dose-limiting toxicity, defined as adverse events of Grade 3 or greater attributable to study drug and require dose reduction or interruption but are not judged to be life-threatening by the protocol team

Countries

United States, Puerto Rico