IMPAACT 1077HS: Examining Benefits of HAART Continuation in Postpartum Women
Condition: HIV Infection
MeSH terms: HIV Infections
Intervention: Highly active antiretroviral therapy (HAART)
Intervention description: 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.
Intervention MeSH terms: Anti-Retroviral Agents
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1653.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV Infection; HAART; Maternal Health

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women age ≥ 18 years or who had attained the minimum age of independent consent, as
             defined by the local Institutional Review Board (IRB), and were willing and able to
             provide written informed consent Additionally, at sites with IRB approval to enroll
             younger participants, women age 16-17 years who were willing and able to provide
             written assent and whose parent or legal guardian was 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 (see
             protocol for more details)

          -  Documentation of hepatitis B surface antibody (HBsAb) status and hepatitis B surface
             antigen (HBsAg) status (if antibody was 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/mm^3 on a specimen obtained within 120 days prior to
             initiation of HAART for current pregnancy

          -  CD4+ cell count ≥ 400 cells/mm^3 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/mm^3

               -  Hemoglobin ≥ 7.0 g/dL

               -  Platelet count ≥ 50,000/mm^3

               -  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 (P1077BF - NCT01061151)

          -  Clinical indication for HAART including any World Health Organization (WHO) Clinical
             Stage 3 or 4 condition, prior or current tuberculosis disease (a positive (Purified
             protein Derivative) PPD test alone was 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 were not required; a heart murmur alone and/or type 1 second-degree
             atrioventricular block (also known as Mobitz I or Wenckebach) was 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 was not required for
             study screening or enrollment but was considered to determine whether treatment for
             HBV was indicated)