Overview

This trial is active, not recruiting.

Condition hiv infection
Treatment highly active antiretroviral therapy (haart)
Phase phase 4
Sponsor International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Collaborator National Institute of Allergy and Infectious Diseases (NIAID)
Start date January 2010
End date August 2016
Trial size 1653 participants
Trial identifier NCT00955968, IMPAACT 1077HS, U01AI068632

Summary

This study is 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 do not otherwise meet criteria to initiate HAART for their own health. The study is designed to determine whether continuation of HAART after delivery or other pregnancy outcome reduces morbidity and mortality compared to discontinuation and re-initiation of HAART according to current standards of care.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Participants will continue receiving HAART after delivery or other pregnancy outcome.
highly active antiretroviral therapy (haart)
A combination of three or more HIV medications belonging to two or more drug classes
(Active Comparator)
Participants will stop receiving HAART after delivery or other pregnancy outcome.
highly active antiretroviral therapy (haart)
A combination of three or more HIV medications belonging to two or more drug classes

Primary Outcomes

Measure
Morbidity and mortality
time frame: Measured at baseline, after 4 and 12 weeks, and then every 3 months until study termination

Secondary Outcomes

Measure
Toxicity and side effects of medications
time frame: Measured at baseline, after 4 and 12 weeks, and then every 3 months until study termination
Emergence of HIV resistance
time frame: Measured at baseline, after 4 and 12 weeks, and then every 3 months until study termination
Medication adherence
time frame: Measured at baseline, after 4 and 12 weeks, and then every 3 months until study termination
Quality of life
time frame: Measured at baseline, after 4 and 12 weeks, and then every 3 months until study termination
Cost effectiveness and feasibility of treatment models
time frame: Measured at baseline, after 4 and 12 weeks, and then every 3 months until study termination
Symptoms and lab values associated with clinical events
time frame: Measured at baseline, after 4 and 12 weeks, and then every 3 months until study termination
Incidence of AIDS-defining illnesses and other select medical conditions
time frame: Measured at baseline, after 4 and 12 weeks, and then every 3 months until study termination

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Women age > 18 years or who have attained the minimum age of independent consent, as defined by the local IRB, and are willing and able to provide written informed consent Additionally, at sites with IRB approval to enroll younger participants, women age 16-17 years who are willing and able to provide written assent and whose parent or legal guardian is willing and able to provide written informed consent - Confirmed HIV infection, documented by positive results from two samples collected at different time points prior to study entry, using protocol-specified tests - Documentation of hepatitis B surface antibody (HBsAb) status and hepatitis B surface antigen (HBsAg) status (if antibody is negative) within 12 months prior to study entry - Within 0-42 days after pregnancy outcome - Antiretroviral treatment naïve, defined as < 14 days of one or more antiretroviral agents, prior to therapy initiated during current pregnancy - Receipt of at least four weeks of HAART prior to study entry, at least two weeks of which must have been prior to pregnancy outcome (up to seven consecutive days of missed therapy is permitted) - CD4+ cell count ≥ 400 cells/mm3 on a specimen obtained within 120 days prior to initiation of HAART for current pregnancy - CD4+ cell count ≥ 400 cells/mm3 on a specimen obtained on HAART and within 45 days prior to study entry - The following laboratory values on a specimen obtained within 45 days prior to study entry: - Absolute neutrophil count ≥ 750/mm3 - Hemoglobin ≥ 7.0 g/dL - Platelet count ≥ 50,000/mm3 - AST (SGOT), ALT (SGPT), and alkaline phosphatase ≤ 2.5 x ULN - Estimated creatinine clearance of ≥ 60mL/min within 45 days prior to entry using the Cockcroft-Gault formula - Intent to remain in current geographical area of residence for the duration of the study - Willingness to attend study visits as required by the study Exclusion Criteria: - Previous participation in PROMISE (P1077) - Clinical indication for HAART including any WHO Clinical Stage 3 or 4 condition, prior or current tuberculosis disease (a positive PPD test alone is not considered exclusionary), and/or any other clinical indication per country-specific treatment guidelines - Clinically significant illness or condition requiring systemic treatment and/or hospitalization within 30 days prior to study entry - Social or other circumstances which, in the opinion of the site investigator, would hinder long-term follow up - Use of any prohibited medications within 14 days prior to study entry (refer to the study MOP for a list of prohibited medications) - Current compulsory detention (involuntary incarceration) in a correctional facility, prison, or jail for legal reasons or compulsory detention in a medical facility for treatment of either a psychiatric or physical (e.g., infectious disease) illness - Currently breastfeeding or planning to breastfeed - Current documented conduction heart defect (specialized assessments to rule out this condition are not required; a heart murmur alone and/or type 1 second-degree atrioventricular block (also known as Mobitz I or Wenckebach) is not considered exclusionary) - Known evidence of HBV DNA levels >2000 IU/mL (approximately 10,000 copies/mL) in the presence of elevated (grade 1 and higher) ALT (HBV DNA testing is not required for study screening or enrollment but should be considered to determine whether treatment for HBV is indicated)

Additional Information

Official title IMPAACT 1077HS: HAART Standard Version of the Promoting Maternal and Infant Survival Everywhere (PROMISE) Study
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by International Maternal Pediatric Adolescent AIDS Clinical Trials Group.