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

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ClinicalTrials.gov Identifier: NCT02400021
Recruitment Status : Unknown
Verified July 2015 by Mount Sinai Hospital, Canada.
Recruitment status was:  Not yet recruiting
First Posted : March 26, 2015
Last Update Posted : July 30, 2015
Sponsor:
Collaborator:
CIHR Canadian HIV Trials Network
Information provided by (Responsible Party):
Mount Sinai Hospital, Canada

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.


Condition or disease Intervention/treatment Phase
HIV-1 Infection Drug: Prometrium Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Progesterone Supplementation for HIV-positive Pregnant Women on Anti-Retrovirals
Study Start Date : August 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Prometrium
Prometrium (progesterone capsules) intervention
Drug: Prometrium
Other Name: progesterone capsules

No Intervention: No treatment
no treatment arm



Primary Outcome Measures :
  1. Total enrollment / eligible population per year [ Time Frame: 12 months ]
    Qualitative information on the reasons to decline participation will be collected and summarized. Reasons for non-enrolling questionnaire will be used.


Secondary Outcome Measures :
  1. Safety of progesterone supplementation during pregnancy for HIV-positive women. [ Time Frame: 40 weeks ]
    The number of Grade 3 or 4 AE in the ITT vs. comparator group. The number of Grade 1 or 2 AE in the ITT vs. comparator group. AE questionnaire.

  2. Acceptability of progesterone supplementation during pregnancy for HIV+ women. [ Time Frame: 40 weeks ]
    Assessed in the ITT group. Acceptability based on experience with medication questionnaire. Screening questionnaire (acceptability of being recruited to no treatment arm)

  3. Compliance of progesterone supplementation. Assessed in the ITT group. [ Time Frame: 40 weeks ]
    Number of missed doses / total prescribed doses per patient. Compliance questionnaire

  4. Barriers to adherence to progesterone supplementation. Assessed in the ITT group [ Time Frame: 40 weeks ]
    Reasons for missed dose questionnaire. Reasons for missed appointment questionnaire


Other Outcome Measures:
  1. Serum progesterone levels at GW25-28 and GW33-36, described by treatment group. [ Time Frame: 28 weeks, 36 weeks ]
    SD and intra-patient correlation coefficient of trough serum progesterone levels will be calculated

  2. Urine progesterone levels at GW25-28 and GW33-36, described by treatment group [ Time Frame: 28 weeks, 36 weeks ]
    SD and intra-patient correlation coefficient will be calculated.

  3. Distribution of birth weight, birth weight percentile, and gestational age at birth, compared by treatment group. [ Time Frame: 40 weeks ]
    ITT and on-treatment analysis

  4. Relationship between progesterone levels (serum or urine) at GW25-28 or GW33-36 and birth weight, birth weight percentile, and gestation age at birth. [ Time Frame: 28 weeks, 36 weeks ]
    assessed with spearman's rank correlation

  5. Serum/urine progesterone levels compared between women with and without an AE/SAE. [ Time Frame: 40 weeks ]
  6. Biomarker analysis [ Time Frame: 40 weeks ]
    levels of sex steroids, angiogenic, vasoactive, and inflammatory factors, factors associated with placentation, placenta dysfunction, pre-term delivery and fetal growth restriction between treatment groups

  7. Placenta morphology between treatment groups [ Time Frame: 40 weeks ]
    Qualitative assessment performed blinded to the arm allocation and birth outcome

  8. Progesterone supplementation effect on PI drug levels [ Time Frame: 40 weeks ]
    trough PI drug levels in plasma collected from women in both tx groups at baseline and each study visit. changes in drug levels over time will be evaluated.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02400021


Contacts
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Contact: Lena Serghides, PhD 647-230-7450 lena.serghides@utoronto.ca

Locations
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Canada, Ontario
St. Joseph's Hospital Not yet recruiting
London, Ontario, Canada, N6A 4V2
Contact: Lena Serghides    647-230-7450    lena.serghides@utoronto.ca   
Principal Investigator: Michael Silverman         
St. Michael's Hospital Not yet recruiting
Toronto, Ontario, Canada, M5C 2T2
Contact: Lena Serghides    647-230-7450    lena.serghides@utoronto.ca   
Principal Investigator: Mark Yudin, MD         
Maple Leaf Medical Clinic Not yet recruiting
Toronto, Ontario, Canada, M5G 1K2
Contact: Lena Serghides    647-230-7450    lena.serghides@utoronto.ca   
Principal Investigator: Mona Loutfy, MD         
Mount Sinai Hospital Not yet recruiting
Toronto, Ontario, Canada, M5G 1Z5
Contact: Lena Serghides    647-230-7450    lena.serghides@utoronto.ca   
Principal Investigator: Kellie Murphy, MD         
Toronto General Hospital Not yet recruiting
Toronto, Ontario, Canada, M5G 2N2
Contact: Lena Serghides    647-230-7450    lena.serghides@utoronto.ca   
Principal Investigator: Sharon Walmsley, MD         
Sponsors and Collaborators
Mount Sinai Hospital, Canada
CIHR Canadian HIV Trials Network
Investigators
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Principal Investigator: Sharon Walmsley, MD Toronto General Research Institute, UHN
Principal Investigator: Kellie Murphy, MD Mount Sinai Hospital, Canada

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT02400021     History of Changes
Other Study ID Numbers: CTNPT025
First Posted: March 26, 2015    Key Record Dates
Last Update Posted: July 30, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
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Progesterone
Anti-Retroviral Agents
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents