HIV-1 InfectionPhase 2ProSPARNCT02400021
Progesterone Supplementation for HIV-positive Pregnant Women on Anti-Retrovirals
A Phase 2 study testing Prometrium in people with HIV-1 Infection, run by Mount Sinai Hospital, Canada at 5 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV-1 Infection
- What is being tested?
- Prometrium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 5 sitesCanada
- Study dates
- Aug 2015to Dec 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
St. Joseph's Hospital
London, Ontario, N6A 4V2
Lena Serghides, 647-230-7450, lena.serghides@utoronto.ca
Michael Silverman
St. Michael's Hospital
Toronto, Ontario, M5C 2T2
Lena Serghides, 647-230-7450, lena.serghides@utoronto.ca
Mark Yudin, MD
Maple Leaf Medical Clinic
Toronto, Ontario, M5G 1K2
Lena Serghides, 647-230-7450, lena.serghides@utoronto.ca
Mona Loutfy, MD
Mount Sinai Hospital
Toronto, Ontario, M5G 1Z5
Lena Serghides, 647-230-7450, lena.serghides@utoronto.ca
Kellie Murphy, MD
Toronto General Hospital
Toronto, Ontario, M5G 2N2
Lena Serghides, 647-230-7450, lena.serghides@utoronto.ca
Sharon Walmsley, MD
About this study
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
- Being tested
- Prometrium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrometriumDrug
Also called progesterone capsules
| Study group | Role | What they receive |
|---|---|---|
| Prometrium | Experimental | Prometrium (progesterone capsules) intervention Receives: Drug: Prometrium |
| No treatment | No intervention | no treatment arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total enrollment / eligible population per year
Qualitative information on the reasons to decline participation will be collected and summarized. Reasons for non-enrolling questionnaire will be used.
Measured: 12 months
Secondary outcomes (4)
Safety of progesterone supplementation during pregnancy for HIV-positive women.
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.
Measured: 40 weeks
Acceptability of progesterone supplementation during pregnancy for HIV+ women.
Assessed in the ITT group. Acceptability based on experience with medication questionnaire. Screening questionnaire (acceptability of being recruited to no treatment arm)
Measured: 40 weeks
Compliance of progesterone supplementation. Assessed in the ITT group.
Number of missed doses / total prescribed doses per patient. Compliance questionnaire
Measured: 40 weeks
Barriers to adherence to progesterone supplementation. Assessed in the ITT group
Reasons for missed dose questionnaire. Reasons for missed appointment questionnaire
Measured: 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-1 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- CIHR Canadian HIV Trials Network
- Responsible party
- Sponsor
- Investigators
- Sharon Walmsley, MD, Principal investigator, Toronto General Research Institute, UHNKellie Murphy, MD, Principal investigator, Mount Sinai Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02400021
- Sponsor's protocol ID
- CTNPT025
- Acronym
- ProSPAR
- Status last verified
- Jul 2015
- First submitted
- 23 Mar 2015
- Last updated
- 30 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27965866
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progesterone Supplementation for HIV-positive Pregnant Women on Anti-Retrovirals
- ClinicalTrials.gov ID
- NCT02400021
- Acronym / sponsor ID
- ProSPAR / CTNPT025
- Conditions
- HIV-1 Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Collaborators
- CIHR Canadian HIV Trials Network
- Study start
- Aug 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 26 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prometrium | Experimental | Drug: PrometriumPrometrium (progesterone capsules) intervention |
| No treatment | No intervention | –no treatment arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- Hypersensitivity or allergy to soya or peanut (non-active ingredient supplement in Prometrium)
- Contraindications to intravaginal progesterone use including:
- Known lethal fetal anomaly
- Any contraindication to continuation of pregnancy
- Inability to communicate in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrometriumAlso: progesterone capsules | Drug | Prometrium |
Primary outcome
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.
4 secondary outcomes
Safety of progesterone supplementation during pregnancy for HIV-positive women.
Time frame: 40 weeks
Acceptability of progesterone supplementation during pregnancy for HIV+ women.
Time frame: 40 weeks
Compliance of progesterone supplementation. Assessed in the ITT group.
Time frame: 40 weeks
Barriers to adherence to progesterone supplementation. Assessed in the ITT group
Time frame: 40 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2015.
- Derived from this study: PubMed 27965866Siou 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon Walmsley, MD principal investigator
Toronto General Research Institute, UHN
Kellie Murphy, MD principal investigator
Mount Sinai Hospital, Canada
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prometrium in people with HIV-1 Infection, run by Mount Sinai Hospital, Canada at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lena Serghides, PhD (647-230-7450, lena.serghides@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total enrollment / eligible population per year (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02400021, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2015.