IMPAACT 1077HS: 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: August 5, 2015
Last verified: August 2015

August 7, 2009
August 5, 2015
January 2010
August 2016   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00955968 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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: No ]
  • 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 ]
Not Provided
Not Provided
 
IMPAACT 1077HS: Examining Benefits of HAART Continuation in Postpartum Women
IMPAACT 1077HS: HAART Standard Version of the Promoting Maternal and Infant Survival Everywhere (PROMISE) Study

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infection
Drug: Highly active antiretroviral therapy (HAART)
A combination of three or more HIV medications belonging to two or more drug classes
  • Experimental: Continue HAART
    Participants will continue receiving HAART after delivery or other pregnancy outcome.
    Intervention: Drug: Highly active antiretroviral therapy (HAART)
  • Active Comparator: Stop HAART
    Participants will stop receiving HAART after delivery or other pregnancy outcome.
    Intervention: Drug: Highly active antiretroviral therapy (HAART)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1653
August 2016
August 2016   (final data collection date for primary outcome measure)

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)
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Botswana,   Brazil,   China,   Haiti,   Peru,   Puerto Rico,   Thailand
 
NCT00955968
IMPAACT 1077HS, U01AI068632
Yes
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study Chair: Judith S. Currier, MD, MS UCLA-Care Center
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP