NCT01923311 - Two Part Study to Evaluate Pharmacokinetics, Safety, and Antiviral Activity of Elvitegravir Administered With a PI/r Background Regimen for ARV Treatment-Experienced Pediatric Participants | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

August 26, 2013

Primary Completion Date

November 3, 2017

Study Completion Date

November 3, 2017

Conditions

Acquired Immune Deficiency Syndrome (AIDS)HIV Infections

Interventions

DRUG

EVG

Tablet (s) or tablet (s) for oral suspension (if unable to swallow) will be administered orally once daily

DRUG

Background regimen

Background regimen may consist of the following ritonavir (RTV)-boosted PIs (PI/r): lopinavir/r (Kaletra), atazanavir/r, darunavir/r, tipranavir/r, or fosamprenavir/r. For participants \< 2 months old, only lopinavir/r is allowed. Use of additional antiretrovirals in background therapy may be allowed.

Trial Locations (11)

2112

Rahima Moosa Mother and Child Hopsital, Johannesburg

7646

Be Part Yoluntu Centre, Cape Town

10330

Thai Red Cross AIDS Research Centre (HIV-NAT), Bangkok

10700

Siriraj Hospital, Bangkok

27100

Universita degli Studi di Pavia - Fondazione IRCCS Policlinico San Matteo, Pavia

27710

Duke University Medical Center, Durham

28041

Hospital 12 de Octubre, Madrid

28095

Hospital Universitario De Getafe, Getafe

38105

St. Jude Children's Research Hospital, Memphis

80045

University of Colorado Denver, Aurora

Unknown

Joint Clinical Research Centre, Kampala