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

NCT ID: NCT02400021

Last Updated: 2015-07-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2016-12-31

Brief 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.

Conditions

HIV-1 Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Prometrium

Prometrium (progesterone capsules) intervention

Group Type: EXPERIMENTAL

Prometrium

Intervention Type: DRUG

No treatment

no treatment arm

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Prometrium

Intervention Type: DRUG

Other Intervention Names

progesterone capsules

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

CIHR Canadian HIV Trials Network

NETWORK

Sponsor Role: collaborator

Mount Sinai Hospital, Canada

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sharon Walmsley, MD

Role: PRINCIPAL_INVESTIGATOR

Toronto General Research Institute, UHN

Kellie Murphy, MD

Role: PRINCIPAL_INVESTIGATOR

Mount Sinai Hospital, Canada

Locations

St. Joseph's Hospital

London, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

Maple Leaf Medical Clinic

Toronto, Ontario, Canada

Mount Sinai Hospital

Toronto, Ontario, Canada

Toronto General Hospital

Toronto, Ontario, Canada

Countries

Canada

Central Contacts

Lena Serghides, PhD

Role: CONTACT

lena.serghides@utoronto.ca

647-230-7450

Facility Contacts

Lena Serghides

Role: primary

lena.serghides@utoronto.ca

647-230-7450

Lena Serghides

Role: primary

lena.serghides@utoronto.ca

647-230-7450

Lena Serghides

Role: primary

lena.serghides@utoronto.ca

647-230-7450

Lena Serghides

Role: primary

lena.serghides@utoronto.ca

647-230-7450

Lena Serghides

Role: primary

lena.serghides@utoronto.ca

647-230-7450

References

Siou K, Walmsley SL, Murphy KE, Raboud J, 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 Feasibility Stud. 2016 Aug 12;2:49. doi: 10.1186/s40814-016-0087-6. eCollection 2016.

Reference Type: DERIVED

PMID: 27965866 (View on PubMed)

Other Identifiers

CTNPT025

Identifier Type: -

Identifier Source: org_study_id