Examining Benefits of HAART Continuation in Postpartum Mothers

This study is currently recruiting participants.
Verified December 2013 by International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00955968
First received: August 7, 2009
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

The purpose of this study is to see if pregnant women receiving highly active antiretroviral treatment (HAART) to prevent mother-to-child transmission of HIV will be healthier if, after delivery, they continue or stop HAART.


Condition Intervention Phase
HIV Infections
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: 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 ]

Estimated Enrollment: 2000
Study Start Date: January 2010
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Continue HAART
Participants will continue receiving HAART after delivery of their babies.
Drug: Highly active antiretroviral therapy (HAART)
A standard 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 of their babies.
Drug: Highly active antiretroviral therapy (HAART)
A standard combination of three or more HIV medications belonging to two or more drug classes

Detailed Description:

Highly active antiretroviral therapy (HAART) is not recommended immediately for all HIV-infected people, only those who have significant illnesses or a cluster of differentiation 4 (CD4) count below 350. However, in pregnancy, HIV-infected women are recommended to start HAART regardless of their own HIV progression for prevention of mother-to-child transmission (pMTCT) of HIV. Women who begin taking HAART for pMTCT often stop treatment after delivery, but new data in non-pregnant adults indicates that stopping treatment may lead to negative long-term health outcomes. This study will examine whether it is healthier for pregnant, HIV-infected women receiving HAART for pMTCT to continue or stop treatment.

Participation in this study will be of variable length; participants will be recruited over four years, and all participants will continue to be followed until 84 weeks after the last woman is assigned to a study group. Participants will be randomly assigned to one of two groups: one group will stop HAART and the other will continue HAART. Participants assigned to stop HAART will receive instructions from the study staff on how and when to stop taking medications. These participants will be monitored and will start treatment again if their HIV progresses.

The first study visit will take place within 28 days of delivery, and subsequent visits will occur after 4 weeks, 12 weeks, and then every 3 months until the end of the study. During these study visits, participants will complete questionnaires and interviews about medication history, receive a physical exam, and have blood and urine collected for HIV blood tests and pregnancy tests. Participants will also be asked if they are willing to have some of their blood stored to be used in later testing.

  Eligibility

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

Inclusion Criteria:

  • At least 18 years old or having attained the minimum age of independent consent, as defined by the local institutional review board (IRB), whichever is greater
  • Confirmed HIV infection, documented by the results of tests performed on two separate specimens at any time prior to study entry
  • Documentation of hepatitis C (HCV) antibody, hepatitis B surface antibody (HBsAb), and hepatitis B surface antigen (HBsAg) status (if HBsAb status is negative) within 12 months prior to study entry
  • Between delivery and 28 days postpartum
  • Antiretroviral (ARV) treatment naïve, defined as having received less than 14 days of one or more antiretroviral agents prior to therapy initiated during current pregnancy NOTE: History of receipt of ARV for perinatal mother-to-child transmission (PMTCT) during prior pregnancies and immediately postpartum is permitted.
  • Receipt of at least 4 weeks of HAART without interruption prior to study entry, at least 2 weeks of which must have been received prior to delivery. HAART is defined as three or more agents from two or more classes of antiretroviral therapy (ART). Treatment interruption is defined as more than seven consecutive days of missed therapy.

NOTE: Women on a triple nucleoside regimen during pregnancy are eligible but will be switched to a study-provided HAART regimen if randomized to continue HAART (Arm A).

  • CD4 cell count of 400 cells/mm3 or greater on a specimen obtained within 60 days prior to initiation of HAART for current pregnancy

NOTE: This result will be obtained from the participant's medical records, if available.

  • CD4 cell count of 400 cells/mm3 or greater on HAART and on a specimen obtained within 45 days prior to study entry
  • Certain laboratory values on a specimen obtained within 45 days prior to study entry. More information on this criterion can be found in the protocol.
  • Estimated creatinine clearance greater than or equal to 60 milliliters (mL)/min within 45 days prior to entry
  • Intent to remain in current geographical area of residence for the duration of the study
  • Willingness to attend visits required by the study

Exclusion Criteria:

  • Previous participation in PROMISE study (P1077)
  • Receipt of tuberculosis (TB) treatment within 30 days of study entry
  • Clinical indication for HAART, defined as WHO Clinical Stage 3 or 4
  • Serious illness requiring systemic treatment and/or hospitalization until participant either completes therapy or is clinically stable on therapy, in the opinion of the investigator, for at least 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 manual of procedures [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 breast feeding or planning to breast feed
  • History of documented structural or conduction heart defect (specialized assessments to rule out this condition are not required, and a heart murmur alone is not considered exclusionary)
  • Known evidence of Hepatitis B virus (HBV) DNA levels greater than 2000 IU/mL (approximately 10,000 copies/mL) in the presence of elevated ALT (testing for this is not required for study screening or enrollment)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00955968

  Show 70 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

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: December 12, 2013
Health Authority: United States: Federal Government

Keywords provided by International Maternal Pediatric Adolescent AIDS Clinical Trials Group:
Perinatal Transmission of HIV
HAART
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on April 15, 2014