Progesterone Supplementation for HIV-positive Pregnant Women on Anti-Retrovirals (ProSPAR)

Mount Sinai Hospital, Canada

Status and phase

Unknown

Phase 2

Conditions

HIV-1 Infection

Treatments

Drug: Prometrium

Study type

Interventional

Funder types

Other

NETWORK

Identifiers

NCT02400021

CTNPT025

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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