IMPAACT 2006 (DAIDS ID 12069): NextGen Strategy Trial: A Phase II, Randomized Study Assessing Lopinavir/Ritonavir-and Dolutegravir-Based Antiretroviral Treatment in Infants and Children >= 1 Month to < 3 Years of Age

Study Status Study Restriction

In Development

Non-US

What is IMPAACT 2006?

IMPAACT 2006 is a Phase II, randomized study to establish the 48-week virologic efficacy and tolerability of two antiretroviral treatment regimens for children < 3 years of age. Approximately 200 participants will be enrolled from international IMPAACT sites into a lopinavir/ritonavir-based antiretroviral regimen or a dolutegravir-based antiretroviral regimen. The study will assess performance characteristics through 48 weeks of follow-up of both regimens and conduct intensive and population pharmacokinetics analyses.

 

Sites where the study is implemented:

CRS ID Site Name City Country

5082

Hospital General de Agudos Buenos Aires Argentina NICHD CRS

Buenos Aires

Argentina

5119

Fundacion Huesped, Hospital Juan A Fernandez NICHD CRS

Buenos Aires

Argentina

12701

Gaborone Prevention/Treatment Trials CRS

Gaborone

Botswana

12702

Molepolole Prevention/Treatment Trials CRS

Molepolole

Botswana

5071

Inst of Pediatrics Fed Univ Rio de Janeiro NICHD CRS

Rio de Janeiro

Brazil

5072

Hospital dos Servidores Rio de Janeiro

Rio de Janeiro

Brazil

5073

SOM Federal University Minas Gerais Brazil

Minas Gerais

Brazil

5074

Univ of Sao Paulo Brazil

Sao Paulo

Brazil

5097

Hosp. Geral De Nova Iguacu Brazil NICHD CRS

Rio de Janeiro, Rio de Janeiro

Brazil

5117

Hospital Nossa Senhora da Conceicao CRS

Porto Alegre

Brazil

31441

BJ Medical College CRS

Pune, Maharashtra

India

5121

Kenya Medical Research Institute - Walter Reed Project Clinical Research Center

Kericho

Kenya

12001

University of North Carolina Lilongwe CRS

Lilongwe

Malawi

8051

Shandukani Research CRS

Johannesburg

South Africa

8052

Soweto IMPAACT CRS

Johannesburg

South Africa

30300

CAPRISA Umlazi Clinical Research Site (UKZN)

Umlazi, KwaZulu-Natal

South Africa

5118

Kilimanjaro Christian Medical CRS

Moshi

Tanzania

5115

Siriraj Hospital Mahidol University CRS

Bangkok

Thailand

5116

Chiang Rai Regional Hospital CRS

Muang

Thailand

31798

Baylor-Uganda CRS

Kampala

Uganda

30303

St. Mary's CRS (Zimbabwe)

Chitungwiza

Zimbabwe

30306

Seke North CRS (Zimbabwe)

Harare

Zimbabwe

31890

Harare Family Care CRS

Harare

Zimbabwe

Study contacts:

Study Chair: Paul Palumbo

Study Vice-Chair: Mutsawashe Bwakura-Dangarembizi

DAIDS Medical Officer: Devasena Gnanashanmugam

NICHD Medical Officer: Rohan Hazra

Clinical Trials Specialist: JL Ariansen

Clinical Trials Specialist: Katie McCarthy

CAB representative: Kaggala Robert

Community Program Manager: Marcus Bolton

DAIDS Protocol Pharmacist: Oladapo Alli

Data Manager: Elise Tjaden

Data Manager: Bonnie Zimmer

Investigator: Elaine Abrams

Investigator: Marc Lallemant

Laboratory Data Manager (LDM): Christopher Hensel

Laboratory Specialist: Carolyn Yanavich

Laboratory Technologist: Gerald Tegha

Pharmacologist: Edward Acosta

Statistician: Jane Lindsey

Statistician: Lee-Jen Wei

Westat Representative: Scott Watson

 

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.