P1084s (DAIDS ID 10790): Maternal and Infant Monitoring for Evidence of Toxicity Related to Tenofovir Exposure: The Bone and Kidney Health Substudy of PROMISE

Study Status Study Restriction

Closed to Follow Up

Non-US

What is P1084s?

P1084s is a nested, comparative substudy of HIV-1-infected women and their infants randomized in PROMISE to receive a maternal tenofovir-containing regimen or no maternal tenofovir-containing regimen during pregnancy or breastfeeding for prevention of mother-to-child transmission. This substudy is designed to examine bone, renal and growth outcomes of tenofovir exposure during pregnancy or during breastfeeding in 1077BF and 1077FF.

>> Read more about PROMISE study results

Study documents:

Sites where the study is implemented:

CRS ID Site Name City Country

12001

University of North Carolina Lilongwe CRS

Lilongwe

Malawi

30301

College of Medicine JHU CRS

Blantyre

Malawi

8051

Shandukani Research CRS

Johannesburg

South Africa

8052

Soweto IMPAACT CRS

Johannesburg

South Africa

8950

Stellenbosch University

Cape Town

South Africa

30300

CAPRISA Umlazi Clinical Research Site (UKZN)

Umlazi, KwaZulu-Natal

South Africa

30293

Makerere University - Johns Hopkins University (MU-JHU) Research Collaboration

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 Co-Chair: George Siberry

Study Co-Chair: Lynda Stranix-Chibanda

NICHD Medical Officer: Rohan Hazra

Clinical Trials Specialist: Anne Coletti

Clinical Trials Specialist: Kathleen George

Clinical Trials Specialist: Katie McCarthy

DAIDS Clinical Representative: Judi Miller

Data Manager: Jenna Kearly

Data Manager: Elise Tjaden

Drug Co. Representative: James Rooney

Field Representative: Michele Kelly

Investigator: Allison Agwu

Investigator: Tsungai Chipato

Investigator: Judith Currier

Investigator: Patricia Flynn

Investigator: Mary Glenn Fowler

Investigator: John Shepherd

Laboratory Data Manager (LDM): Rebecca LeBlanc

Laboratory Data Manager (LDM): Amanda Zadzilka

Laboratory Technologist: Amy James Loftis

Laboratory Technologist: William Kabat

Medical Monitor: Renee Browning

Medical Officer: Devasena Gnanashanmugam

Medical Officer: Karin Klingman

Pharmaceutical Company Representative: Melody Billena

Pharmacologist: Mark Mirochnick

Protocol Pharmacist: Lynette Purdue

Statistician: Terence Fenton

Statistician: David Shapiro

Statistician: Meredith Warshaw

CTS: PROMISE Ops

 

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.