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

• Register: ClinicalTrials.gov
• Last refreshed on: 10 August 2015
• Main ID: NCT02400021
• Date of registration: 23/03/2015
• Prospective Registration: Yes
• Primary sponsor: Mount Sinai Hospital, Canada
• Public title: Progesterone Supplementation for HIV-positive Pregnant Women on Anti-Retrovirals ProSPAR
• Scientific title: Progesterone Supplementation for HIV-positive Pregnant Women on Anti-Retrovirals
• Date of first enrolment: August 2015
• Target sample size: 40
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT02400021
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Canada

Contacts

• Name: Lena Serghides, PhD

• Name: Sharon Walmsley, MD
• Affiliation: Toronto General Research Institute, UHN

• Name: Kellie Murphy, MD
• Affiliation: Mount Sinai Hospital, Toronto, Ontario

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

HIV-1 Infection

Intervention(s)

Drug: Prometrium

Primary Outcome(s)

Total enrollment / eligible population per year [Time Frame: 12 months]

Secondary Outcome(s)

Safety of progesterone supplementation during pregnancy for HIV-positive women. [Time Frame: 40 weeks]

Compliance of progesterone supplementation. Assessed in the ITT group. [Time Frame: 40 weeks]

Acceptability of progesterone supplementation during pregnancy for HIV+ women. [Time Frame: 40 weeks]

Barriers to adherence to progesterone supplementation. Assessed in the ITT group [Time Frame: 40 weeks]

Secondary ID(s)

CTNPT025

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

CIHR Canadian HIV Trials Network