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

Enrolling

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

Version 3.0

Version 2.0

» IMPAACT 2017 MOP and Implementation Tools

» Study Trainings

Sites where the study is implemented:

CRS ID Site Name City Country

12701

Gaborone Prevention/Treatment Trials CRS

Gaborone

Botswana

12702

Molepolole Prevention/Treatment Trials CRS

Molepolole

Botswana

8051

Wits RHI Shandukani Research Centre CRS

Johannesburg

South Africa

8052

Soweto IMPAACT CRS

Johannesburg

South Africa

8950

Family Clinical Research Unit (FAM-CRU) CRS

Cape Town

South Africa

30300

CAPRISA Umlazi Clinical Research Site (UKZN)

Umlazi, KwaZulu-Natal

South Africa

5115

Siriraj Hospital Mahidol University CRS

Bangkok

Thailand

5116

Chiang Rai Regional Hospital CRS

Chiang Rai

Thailand

31784

Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS

Chiang Mai

Thailand

30293

Makerere University - Johns Hopkins University (MU-JHU CARE LTD) Research Collaboration CRS

Kampala

Uganda

31798

Baylor-Uganda CRS

Kampala

Uganda

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: Bill Kapogiannis

Clinical Trials Specialist: Sarah Buisson

Clinical Trials Specialist: Katherine Calabrese

CAB representative: Joel Pagan-Lizardi

Community Program Manager: Cheryl Blanchette

Data Manager: Barbara Heckman

Data Manager: Jared Kneebone

Data Manager: Yvonne Woolwine-Cunningham

Investigator: Elizabeth Lowenthal

Laboratory Data Manager (LDM): Kathleen (Katie) Trabert

Laboratory Data Manager (LDM): Kyle Whitson

Laboratory Specialist: Frances Whalen

Laboratory Technologist: Patrick Karugaba

Pharmacologist: Brookie Best

Pharmacologist: Edmund Capparelli

Pharmacologist: Mark Marzinke

Protocol Pharmacist: Irene Rwakazina

Statistician: Pearl Samson

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.