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

• Status: Completed
• Trial end date: 2018-12-11
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID); Westat
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Efavirenz; Lamivudine; Lamivudine, zidovudine drug combination; Raltegravir Potassium; Reverse Transcriptase Inhibitors; Zidovudine

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