Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Lamivudine/zidovudine; Efavirenz; Raltegravir
Intervention description: Participants received one lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet twice a day from entry through delivery*.
* Participants may have received a locally supplied nucleoside reverse transcriptase inhibitor (NRTI) backbone in place of lamivudine/zidovudine with permission of the protocol team obtained prior to randomization.; Participants received one 600 mg tablet of efavirenz each night from entry through delivery.; Participants received one 400 mg raltegravir tablet twice a day from entry through delivery.
Intervention MeSH terms: Lamivudine; Zidovudine; Efavirenz; Lamivudine, zidovudine drug combination; Raltegravir Potassium
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 408.0
Sex: Female
Minimum age: 16 Years
Healthy volunteers: No

Summary:

      HIV-infected pregnant women who begin taking antiretroviral (ARV) medications in the late
      stages of pregnancy need an effective medication regimen to reduce the risk of transmitting
      HIV to their children. This study examined the virologic response, safety, and tolerability
      of two different ARV medication regimens in HIV-infected pregnant women who were between 20
      and 36 weeks pregnant when they entered the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Naive to antiretroviral therapy (ART) or have received ART with short course
             zidovudine (maximum of 8 weeks) for prevention of mother-to-child transmission in
             previous pregnancies

          -  Willing and able to sign informed consent. Participant must be of an age to provide
             legal informed consent as defined by the country in which the participant resides. If
             not, the informed consent must be signed by a legal guardian/parent, as per country
             guidelines.

          -  Documentation of HIV-1 infection defined as positive results from two samples
             collected at different time points. The same method may be used at both time points.
             All samples tested must be whole blood, serum, or plasma. Documentation may be
             abstracted from medical records to satisfy these criteria for infection. More
             information on this criterion can be found in the protocol.

          -  Viable pregnancy with gestational age of greater than or equal to 20 weeks to less
             than or equal to 36 weeks based upon menstrual history and/or ultrasound. Note: If
             menstrual history is unknown or if there is a discrepancy between menstrual history
             and ultrasound, determination of gestational age should be based upon best available
             methodology at each site.

          -  Intends to continue pregnancy

          -  Willingness and intent to deliver at the participating clinical site and to be
             followed for the duration of the study at the site or associated outpatient facility

          -  Willing to comply with the study regimen

          -  Agrees to use two reliable methods of contraception after delivery if randomized to
             the efavirenz arm and is sexually active. A barrier method of contraception (condoms,
             diaphragm, or cervical cap) together with another reliable form of contraception must
             be used for 4 weeks after stopping efavirenz.

        Exclusion Criteria:

          -  Active labor defined as onset of regular contractions or cervical dilatation greater
             than 2 cm

          -  Use of ART during current pregnancy

          -  Chemotherapy for active malignancy

          -  HIV genotypic resistance, as defined in the protocol, to efavirenz or raltegravir or
             to NRTIs that will be included in the ART regimen. Note: A lack of HIV drug resistance
             test results at the time of enrollment is not exclusionary.

          -  Serious active opportunistic infection and/or serious bacterial infection including
             active tuberculosis (TB) or unstable or severe medical condition within 14 days of
             study entry

          -  Active drug or alcohol use or dependence that, in the opinion of the site
             investigator, would interfere with adherence to study requirements

          -  Any clinically significant diseases (other than HIV infection) or clinically
             significant findings during the screening medical history or physical examination
             that, in the investigator's opinion, would compromise the outcome of this study

          -  Vomiting or inability to swallow medications due to an active, pre-existing condition
             that prevents adequate swallowing and absorption of study medication

          -  Known allergy/sensitivity to any study drugs or their formulations or sulfonamide
             allergy

          -  The following laboratory values (within 30 days of enrollment):

               1. Hemoglobin greater than or equal to Grade 3

               2. Absolute neutrophil count greater than or equal to Grade 2

               3. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than
                  or equal to Grade 2

               4. Serum creatinine greater than or equal to Grade 1

               5. Platelet count greater than or equal to Grade 3

          -  Evidence of pre-eclampsia (such as persistent diastolic blood pressure greater than 90
             mm Hg)

          -  Receipt of disallowed medications as described in the protocol