Last updated on August 2018

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


Brief description of study

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 will examine the virologic response, safety, and tolerability of two different ARV medication regimens in HIV-infected pregnant women who are between 20 and 36 weeks pregnant when they enter the study.

Detailed Study Description

While there are many ARV medications and combination regimens available to treat HIV-infected people, the number of ARV medications studied in HIV-infected pregnant women for the prevention of mother-to-child transmission remains limited. HIV-infected pregnant women who begin taking ARV medications late in their pregnancies require effective therapy to reduce the risk of transmitting HIV to their children. Currently, there is no data available that compares the effects of non-nucleoside reverse transcriptase inhibitors (NNRTI) and integrase inhibitors (which are two classes of ARV medications) in pregnant women. The purpose of this study is to compare the safety, tolerance, and virologic and pharmacologic responses to two different medication regimens, each including an NNRTI or integrase inhibitor, in pregnant HIV-infected women who begin ARV therapy late in their pregnancies (i.e., a gestational age between 20 and 36 weeks).

Participants in this study will be randomly assigned to one of two arms. Participants in Arm A will receive lamivudine 150 mg/zidovudine 300 mg twice a day and efavirenz 600 mg each night. Participants in Arm B will receive lamivudine 150 mg/zidovudine 300 mg twice a day and raltegravir 400 mg twice a day. All participants will receive their assigned medications from study entry through delivery. Participants will attend study visits at entry and Weeks 1, 2, and 4; and thereafter, every two weeks until labor and delivery. Study visits will include a medical history review, physical examination, questionnaires, blood collection, and a vaginal swab procedure.

While participants are in labor, they will continue to receive their study medications. Some participants may receive additional or alternate medications according to local standard of care/guidelines. Participants will have a physical examination and blood collection. After delivery, some women will continue to receive ARV medications according to the local guidelines. Participants will attend study visits following the delivery at Weeks 2 to 4, 6, 16, and 24, which will include a medical history review, physical examination, and blood collection. One study visit will include a vaginal swab procedure. Some participants may have vaginal specimens stored for future research.

Participants' babies will receive ARV medications as prescribed by the babies' doctors. Study visits for babies will occur at birth; Weeks 2 to 4, 6, 16, and 24. Each study visit will include a medical history review, physical examination, and blood collection. Select visits will include oral and nasopharyngeal swab collection.

Clinical Study Identifier: NCT01618305

Contact Investigators or Research Sites near you

Start Over

Bhumibol Adulyadej Hospital
Bangkok, Thailand
0.69miles