CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,653 enrolled
Drug / intervention
Highly active antiretroviral therapy (HAART)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00955968
NCT00955968Phase 4Completed
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IMPAACT 1077HS: HAART Standard Version of the Promoting Maternal and Infant Survival Everywhere (PROMISE) Study

International Maternal Pediatric Adolescent AIDS Clinical Trials Group·interventional·Posted Aug 10, 2009·Updated Aug 14, 2023

In Brief

A Phase 4 clinical trial evaluating Highly active antiretroviral therapy (HAART) for HIV Infection. Completed, enrolled 1,653 participants across 50 sites in 9 countries.

Detailed Summary

This study was a randomized strategy trial conducted among women who received highly active antiretroviral therapy (HAART) during pregnancy for purposes of prevention of mother-to-child transmission (PMTCT) of HIV but did not otherwise meet criteria to initiate HAART for their own health. The study was designed to determine whether continuation of HAART after delivery or other pregnancy outcome reduced morbidity and mortality compared to discontinuation and re-initiation of HAART when protocol specified criteria were met.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infection
CountriesArgentina, Botswana, Brazil, China, Haiti, Peru, Puerto Rico, Thailand, United States
CollaboratorsNational Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 10, 2009
Enrollment StartJan 1, 2010
Primary CompletionAug 31, 2016
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 16.9 years ago

Interventions

Highly active antiretroviral therapy (HAART)drug

A combination of three or more HIV medications belonging to two or more drug classes. The preferred study-supplied HAART regimen was lopinavir/ritonavir (LPV/RTV) plus fixed dose combination tenofovir/emtricitabine (TDF/FTC). Additional ARVs provided for use in this study included fixed dose combination lamivudine/zidovudine (3TC/ZDV), lamivudine (3TC), zidovudine (ZDV), tenofovir (TDF), fixed dose combination tenofovir/emtricitabine/rilpivirine (TDF/FTC/RPV), didanosine (ddI), atazanavir (ATV), raltegravir (RAL), and ritonavir (RTV). While LPV/RTV plus TDF/FTC was the preferred study-supplied regimen, the study clinicians in conjunction with participants would determine the optimal drug combination for each participant.