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CTNPT 025: ProSPAR

Progesterone Supplementation for HIV-positive Pregnant Women on Anti-Retrovirals

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About the study

This pilot study is being conducted to identify whether the addition of progesterone will improve standard care for pregnant women living with HIV. It aims to determine how safe, well-tolerated, easy-to-use, and acceptable progesterone supplementation is for pregnant women living with HIV. This study involves the participants continuing the usual treatment for HIV-positive pregnant women (including anti-retroviral therapy, or ART), and if assigned to the treatment group, taking progesterone.

About the disease/condition

Standard care for HIV-positive pregnant women involves taking ART medication to prevent mother-to-child transmission and promote maternal health. In Canada, the majority of HIV-positive pregnant women are on ritonavir-boosted, protease inhibitor-based ART. However, multiple studies have shown that this therapy may increase the chances of delivering pre-term (when the baby is born before the 37th week of pregnancy) and having a low birth weight baby (when the baby weighs less than 2.5 kilograms or 5.5 pounds).

Previous research suggests that protease inhibitors may lead to a decrease in progesterone. Progesterone is a very important hormone during pregnancy because it helps maintain a supportive environment for a growing baby. Lower levels of progesterone during pregnancy as a result of protease inhibitor-based ART might contribute to the increased rate of early and low-birth weight deliveries. Supplementing women with progesterone during pregnancy may improve their chances of having a normal weight baby.

In the general population, progesterone supplementation (i.e. Prometrium) is widely used to help prevent a pre-term delivery, especially in pregnant women who have had a pre-term delivery in the past. Progesterone supplementation in pregnancy is well-tolerated and considered safe.

Study Approach

Forty women will participate in this study in different clinics and hospital sites in Ontario. Each will begin the study between weeks 16 and 24 of their pregnancy and will participate up until 4-8 weeks after delivery. Hospital/clinic visits will take place about once every 4 weeks.

Of the 40 participants, 25 will receive progesterone (Group 1) while 15 will receive no treatment and will serve as the comparison group (Group 2). As a result, participants have a greater chance of being placed in Group 1.

  • Group 1 will receive natural progesterone (Prometrium 200 mg), in addition to standard care, and will continue taking the study drug until week 36 of pregnancy.
  • Group 2 will simply continue with standard care alone.

Eligibility criteria

Inclusion Criteria:

  • Documented HIV-1 infection
  • On (stable) or initiating a ART regimen containing either ritonavir-boosted lopinavir, atazanavir , or darunavir
  • Pregnant up to 24 weeks gestational age
  • Singleton pregnancy (not a twin pregnancy)
  • 16 years or older
  • Ability to give informed consent

Exclusion Criteria:

  • Hypersensitivity or allergy to soya or peanut (non-active ingredient supplement in Prometrium)
  • Contraindications to intravaginal progesterone use
  • Known lethal fetal anomaly
  • Any contraindication to continuation of pregnancy
  • Prior experience with intravaginal progesterone administration

For more information on inclusion and exclusion criteria, please refer to clinicaltrials.gov.

Participating sites

Ontario

Toronto General Hospital Immunodeficiency Clinic
585 University Avenue
Toronto, ON M5G 2N2

Maple Leaf Medical Clinic
14 College St
Toronto, ON M5G 1K2

St. Michael’s Hospital Obstetrical Clinic
Women’s Health Centre
61 Queen Street East, 4th Floor
Toronto, Ontario

Mount Sinai Hospital Obstetrical Clinic
600 University Ave
Toronto, ON M5G 1X5

Sunnybrook Health Sciences Centre Obstetrical Clinic
2075 Bayview Ave
Toronto, ON M4N 3M5

St. Joseph’s Health Care Infectious Diseases Care Program (London)
268 Grosvenor Street
London, Ontario  N6A 4V2

Additional Information

If you would like more information on this clinical study, please contact Dr. Lena Serghides: (647) 230-7450, lena.serghides@utoronto.ca

Principal Investigator:

Dr. Kellie Murphy
Mount Sinai Hospital

Publication:

Siou K, Walmsley SL, Murphy KE, Raboud JM, Loutfy M, Yudin MH, Silverman M, Ladhani NN, Serghides L. Progesterone supplementation for HIV-positive pregnant women on protease inhibitor-based antiretroviral regimens (the ProSPAR study): a study protocol for a pilot randomized controlled trial. Pilot and Feasibility Studies. 2016;2(1):795.

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