IMPAACT 2017: Phase I/II Study of the Safety, Acceptability, Tolerability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Long-Acting Injectable Rilpivirine in Virologically Suppressed HIV-Infected Children and Adolescents

Study Status Study Restriction

Open to Accrual

United States

What is IMPAACT 2017 (MOCHA)?

IMPAACT 2017 is a Phase I/II, multi‐center, open‐label, non‐comparative study to confirm the dose and evaluate the safety, tolerability, acceptability, and PK of oral CAB, long-acting injectable CAB (CAB LA), and long-acting injectable RPV (RPV LA) among up to 155 virologically suppressed HIV‐1 infected children and adolescents aged 12 to <18 years. Up to 60 parents/caregivers of adolescent participants will also be enrolled to take part in in-depth qualitative interviews. The MOCHA study (More Options for Children and Adolescents) will enroll two sequential cohorts (Cohort 1 and Cohort 2), each with an oral lead-in phase followed by an injection phase. Cohort 1 will be followed for 16 weeks, whereas Cohort 2 will be followed for 96 weeks. Participants discontinuing study product injections will be followed for an additional 48 weeks to evaluate tolerability and acceptability, and characterize long-term safety and washout PK.

Study Documents

» Study Trainings

 

Sites where the study is implemented:

CRS ID Site Name City Country

3801

Texas Childrens Hosp. CRS

Houston

United States of America

4001

Chicago Children's CRS

Chicago

United States of America

4201

University of Miami Pediatric/Perinatal HIV/AIDS

Miami

United States of America

4601

UCSD Mother-Child-Adolescent HIV Program

San Diego

United States of America

5011

Boston Medical Center Pediatric HIV Program

Boston

United States of America

5013

Jacobi Medical Center Bronx

Bronx

United States of America

5017

Univ of Washington Children's Hospital Seattle

Seattle

United States of America

5030

Emory University School of Medicine NICHD CRS

Atlanta

United States of America

5031

San Juan City Hospital

San Juan

United States of America

5040

SUNY Stony Brook

Stony Brook

United States of America

5048

University of Southern California LA

Los Angeles

United States of America

5051

University of Florida Jacksonville

Jacksonville

United States of America

5052

University of Colorado Denver NICHD CRS

Aurora

United States of America

5055

South Florida CDTC Ft Lauderdale NICHD CRS

Fort Lauderdale

United States of America

5083

Rush University Cook County Hospital Chicago NICHD CRS

Chicago

United States of America

5092

Johns Hopkins University, Baltimore

Baltimore

United States of America

5112

UCLA - David Geffen School of Medicine

Los Angeles

United States of America

5114

Bronx-Lebanon Hospital IMPAACT

Bronx

United States of America

6501

St. Jude/UTHSC CRS

Memphis

United States of America

6601

University of Puerto Rico Pediatric HIV/AIDS Research Program CRS

San Juan

United States of America

Study contacts:

Study Co-Chair: Carolyn Bolton

Study Co-Chair: Aditya Gaur

DAIDS Medical Officer: Adeola Adeyeye

NICHD Medical Officer: Rohan Hazra

Clinical Trials Specialist: Katherine Calabrese

Clinical Trials Specialist: Anna LeViere

CAB representative: Joel Pagan-Lizardi

Community Program Manager: Cheryl Blanchette

Data Manager: Barbara Heckman

Data Manager: Korianne Sulzbach

Laboratory Data Manager (LDM): Kyle Whitson

Laboratory Specialist: William Murtaugh

Pharmacologist: Brookie Best

Pharmacologist: Edmund Capparelli

Protocol Pharmacist: Irene Rwakazina

Statistician: Carmelita Alvero

Statistician: Yan Wang

 

Funded by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health of the US National Institutes of Health, US Department of Health and Human Services.