Examining Benefits of HAART Continuation in Postpartum Women

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00955968
First received: August 7, 2009
Last updated: March 23, 2015
Last verified: March 2015
  Purpose

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.


Condition Intervention Phase
HIV Infection
Drug: Highly active antiretroviral therapy (HAART)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: HAART Standard Version of the Promoting Maternal and Infant Survival Everywhere (PROMISE) Study

Resource links provided by NLM:


Further study details as provided by International Maternal Pediatric Adolescent AIDS Clinical Trials Group:

Primary Outcome Measures:
  • Morbidity and mortality [ Time Frame: Measured at baseline, after 4 and 12 weeks, and then every 3 months until study termination ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Toxicity and side effects of medications [ Time Frame: Measured at baseline, after 4 and 12 weeks, and then every 3 months until study termination ] [ Designated as safety issue: Yes ]
  • Emergence of HIV resistance [ Time Frame: Measured at baseline, after 4 and 12 weeks, and then every 3 months until study termination ] [ Designated as safety issue: Yes ]
  • Medication adherence [ Time Frame: Measured at baseline, after 4 and 12 weeks, and then every 3 months until study termination ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: Measured at baseline, after 4 and 12 weeks, and then every 3 months until study termination ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 1653
Study Start Date: January 2010
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Continue HAART
Participants will continue receiving HAART after delivery or other pregnancy outcome.
Drug: Highly active antiretroviral therapy (HAART)
A combination of three or more HIV medications belonging to two or more drug classes
Active Comparator: Stop HAART
Participants will stop receiving HAART after delivery or other pregnancy outcome.
Drug: Highly active antiretroviral therapy (HAART)
A combination of three or more HIV medications belonging to two or more drug classes

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00955968

  Show 50 Study Locations
Sponsors and Collaborators
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Investigators
Study Chair: Judith S. Currier, MD, MS UCLA-Care Center
  More Information

Additional Information:
No publications provided

Responsible Party: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00955968     History of Changes
Other Study ID Numbers: IMPAACT 1077HS, U01AI068632
Study First Received: August 7, 2009
Last Updated: March 23, 2015
Health Authority: United States: Federal Government

Keywords provided by International Maternal Pediatric Adolescent AIDS Clinical Trials Group:
HIV Infection
HAART
Maternal Health

ClinicalTrials.gov processed this record on March 31, 2015