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

Information source: Mount Sinai Hospital, Canada
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV-1 Infection

Intervention: Prometrium (Drug)

Phase: Phase 2

Status: Not yet recruiting

Sponsored by: Mount Sinai Hospital, Canada

Official(s) and/or principal investigator(s):
Sharon Walmsley, MD, Principal Investigator, Affiliation: Toronto General Research Institute, UHN
Kellie Murphy, MD, Principal Investigator, Affiliation: Mount Sinai Hospital, Toronto, Ontario

Overall contact:
Lena Serghides, PhD, Phone: 647-230-7450, Email: lena.serghides@utoronto.ca

Summary

In pregnancy, cART is considered optimal for maternal health and for preventing the emergence of resistance that could compromise further care. In Canada, the majority of HIV-positive pregnant women receive a PI-based cART regimen. In the past, therapy was generally deferred until after the first trimester (if not required for maternal health) to minimize any unknown risk of teratogenicity. However, as treatment is now started earlier in HIV infection and as perinatal transmission rates are lowest in those with prolonged suppression of viral load during pregnancy, women are increasingly commencing cART either before conception or earlier in pregnancy. Multiple reports and cohort studies provided data suggesting an association between PI-based cART use and preterm birth, low birth weight, and small for gestational age (SGA) babies, although conflicting data exist. In the general population progesterone supplementation is widely used, is well tolerated, is considered safe, and is beneficial to prevent recurrent pre-term birth and increase birth weight. The investigators experimental findings suggest that PI use during pregnancy is associated with declines in progesterone levels that correlate with fetal growth, and that progesterone supplementation can improve PI-induced fetal growth restriction. The investigators preliminary findings in HIV+ pregnant women suggest that PI-use is associated with declines in progesterone levels, which correlate with birth weight percentile. Since HIV-positive women have higher rates of pre-term delivery and low birth weight that may be magnified by the use of PIs, then progesterone supplementation could be of benefit to neonatal health in the context of HIV-positive pregnancy.

Clinical Details

Official title: Progesterone Supplementation for HIV-positive Pregnant Women on Anti-Retrovirals

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Total enrollment / eligible population per year

Secondary outcome:

Safety of progesterone supplementation during pregnancy for HIV-positive women.

Acceptability of progesterone supplementation during pregnancy for HIV+ women.

Compliance of progesterone supplementation. Assessed in the ITT group.

Barriers to adherence to progesterone supplementation. Assessed in the ITT group

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Documented HIV-1 infection

- On (stable) or initiating a cART regimen containing either ritonavir-boosted

lopinavir (LPV/r), atazanavir (ATZ/r) or darunavir (DRV/r)

- Pregnant up to 24 weeks gestational age

- Singleton pregnancy

- 18 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 including:

- documented hypersensitivity to Prometrium

- active or history of breast cancer,

- active or history of arterial thromboembolitic disease (e. g. stroke, myocardial

infarction, coronary heart disease)

- active or history of venous thromboembolism (e. g. deep venous thrombosis or

pulmonary embolism) or active thrombophlebitis

- any prior neoplasia, except for skin

- abnormal vaginal bleeding

- Known lethal fetal anomaly

- Any contraindication to continuation of pregnancy

- Inability to communicate in English

- Prior participation in this trial

Locations and Contacts

Lena Serghides, PhD, Phone: 647-230-7450, Email: lena.serghides@utoronto.ca

St. Joseph's Hospital, London, Ontario N6A 4V2, Canada; Not yet recruiting
Lena Serghides, Phone: 647-230-7450, Email: lena.serghides@utoronto.ca
Michael Silverman, Principal Investigator

Maple Leaf Medical Clinic, Toronto, Ontario M5G 1K2, Canada; Not yet recruiting
Lena Serghides, Phone: 647-230-7450, Email: lena.serghides@utoronto.ca
Mona Loutfy, MD, Principal Investigator

Mount Sinai Hospital, Toronto, Ontario M5G 1Z5, Canada; Not yet recruiting
Lena Serghides, Phone: 647-230-7450, Email: lena.serghides@utoronto.ca
Kellie Murphy, MD, Principal Investigator

St. Michael's Hospital, Toronto, Ontario M5C 2T2, Canada; Not yet recruiting
Lena Serghides, Phone: 647-230-7450, Email: lena.serghides@utoronto.ca
Mark Yudin, MD, Principal Investigator

Toronto General Hospital, Toronto, Ontario M5G 2N2, Canada; Not yet recruiting
Lena Serghides, Phone: 647-230-7450, Email: lena.serghides@utoronto.ca
Sharon Walmsley, MD, Principal Investigator

Additional Information

Starting date: August 2015
Last updated: July 28, 2015

Page last updated: August 23, 2015

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