HIV SeropositivityPhase 1/2DOLPHIN MomsNCT05122026
Safety and Tolerability of 1 Month Daily (1HP) and 3 Months Weekly (3HP) Isoniazid and Rifapentine With Pharmacokinetics of Dolutegravir (DTG) in Pregnant People With HIV
A Phase 1/2 study testing Rifapentine and Isoniazid in people with HIV Seropositivity and Pregnancy, run by The Aurum Institute NPC at 3 sites in South Africa.
Trial summary
Open-label, two-arm, randomized multicenter study to investigate the safety, tolerability, and pharmacokinetics (PK), and potential interactions between dolutegravir (DTG) and rifapentine (RPT) during pregnancy in people with HIV when RPT is given with isoniazid (INH) daily for 4 weeks (1HP) or weekly for 3 months… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV Seropositivity, Pregnancy, Tuberculosis Infection
- What is being tested?
- Rifapentine and Isoniazid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 3 sitesSouth Africa
- Study dates
- 17 Jan 2024to 31 Dec 2025
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- Age > 18 years
- Weight > 50 kg
- Documented HIV infection
- At least 4 weeks of ART and virally suppressed on dolutegravir plus two NRTIs
- Undetectable HIV-1 viral load
- Pregnancy at 20-34 weeks as confirmed by ultrasound
- Singleton pregnancy
Who cannot join
- Confirmed or suspected TB disease
- Likely to move from the study area during the study period
- Known exposure to pulmonary TB cases with known or suspected resistance to isoniazid or rifampicin in the source case
- TB treatment within the past year
- TB preventive therapy within the last year
- Sensitivity or intolerance to isoniazid or rifamycins
Show all 15Show fewer
- On nevirapine, etravirine, rilpivirine, PI-based, or raltegravir-containing ART regimens
- Suspected acute hepatitis or known chronic liver disease; HBsAg positivity; severe hepatic impairment
- Alanine aminotransferase (ALT) ≥ 3 times the upper limit of normal (ULN)
- Total bilirubin ≥ 2.5 times the ULN
- Absolute neutrophil count (ANC) < 750 cells/mm3
- Creatinine clearance < 50 ml/min
- Self-reported alcohol use exceeding 21 units per week
- Karnofsky status < 80
- On prohibited medications e.g. dofetilide
Trial locations and contacts
3 sites in 1 country.
South Africa3 sites
FAMily Centre for Research with Ubuntu (FAMCRU)
Cape Town, Cape Town, 7505
Peri Natal HIV Research Unit - Klerksdorp Tshepong Hospital
Klerksdorp, North West, 2571
The Aurum Institute: Tembisa Clinical Research Centre
Tembisa, Gauteng, 1632
About this study
Open-label, two-arm, randomized multicenter study to investigate the safety, tolerability, and pharmacokinetics (PK), and potential interactions between dolutegravir (DTG) and rifapentine (RPT) during pregnancy in people with HIV when RPT is given with isoniazid (INH) daily for 4 weeks (1HP) or weekly for 3 months (3HP) as part of tuberculosis (TB) preventive therapy (TPT). Adults (age ≥18) who are pregnant with a singleton pregnancy (confirmed by ultrasound) at a gestational age of 20-34 weeks and virally suppressed on an existing DTG-based plus two nucleoside reverse transcriptase inhibitors (NRTI) antiretroviral (ART) regimen for at least four weeks may participate.
Read the detailed description
Enrolled participants will be randomized 1:1 to Arms 1 and 2.
Arm 1: 1HP (n=126):
Participants will start twice-daily DTG on Day 0, and will receive once-daily HP for 28 total doses, starting on Day 1. HIV viral load (VL) will be measured at baseline (screening), week 3 (Day 17), at delivery, and post-partum week 12. Safety labs: complete blood count (CBC), urea and electrolytes (U\&E), creatinine, prothrombin time and international normalized ratio (PT/INR), and liver function tests (LFT) will be obtained at screening for everyone and at follow-up visits, if clinically indicated; CBCs and LFTs will be checked at delivery in all participants.
The first 25 participants enrolled to Arm 1 who consent to be in a PK substudy will participate in sparse PK blood collections for DTG. Sparse PK sampling for DTG will be performed on the morning of Day 1, before starting 1HP and before the morning dose of DTG. Additional sparse PK sampling for DTG will be performed prior to DTG dosing on Day 17 (to track with 72 hours after the 3rd dose of HP in Arm 2).
A plasma specimen for RPT PK will also be collected on Day 17.
Arm 2: 3HP (n=126):
Participants will start twice-daily DTG on Day 0, and will receive once-weekly HP for 12 total doses starting on Day 1. HIV VL will be measured at baseline (screening), week 3 (Day 17), at delivery, and at post-partum week 12. Safety labs: CBC, U\&E, creatinine, PT/INR, and LFTs will be obtained at screening for everyone and at follow-up visits, if clinically indicated; CBCs and LFTs will be drawn at delivery.
The first 25 participants enrolled to Arm 2 who consent to be in a PK substudy will participate in sparse PK blood collections for DTG. Sparse PK sampling for DTG will be performed on the morning of Day 1, before starting 3HP, and before the morning dose of DTG. Additional sparse PK sampling for DTG will be performed on Day 17 prior to DTG dosing (72 hours after the 3rd dose of HP) and on Day 52 prior to DTG dosing (72 hours after the 8th dose of HP).
There will not be plasma collection on Day 17 for RPT PK in Arm 2, because specimen collection would be 72 hours after the weekly HP dose and a RPT level will likely not be detectable.
Interim analysis will occur when 25 participants each from Arms 1 and 2 have completed the Week 3 (Day 17) sparse PK visit. Ongoing enrolment will not be paused during the interim analysis, which will assess DTG PK, safety, and VL data.
Enrollment will be paused if accrual to each arm reaches 101 participants before the interim analysis has been completed. Once results are available, then enrollment will restart with dosing (daily vs. BID) based on the DTG PK results.
- Conditions
- HIV Seropositivity, Pregnancy, Tuberculosis Infection
- Being tested
- Rifapentine, Isoniazid
- Keywords
- Dolutegravir, 3HP, Rifapentine, pharmacokinetic, TB preventive treatment
- Medical subject headings
- HIV Seropositivity, Latent Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RifapentineDrug
Also called Priftin
As included in arm/group description
IsoniazidDrug
Also called Winthrop Isoniazid
As included in arm/group description
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: One month of daily isoniazid and rifapentine (4 weeks) | Experimental | * DTG 50 mg orally BID
* DTG 50 mg + 2 NRTI each morning (non-study)
* 2nd dose: DTG 50 mg each evening (during 1HP)
* 1HP: INH 300 mg + RPT 600 mg each morning for 4 weeks Receives: Drug: Rifapentine; Drug: Isoniazid |
| Arm 2: Three months of once-weekly isoniazid and rifapentine (12 weeks) | Experimental | * DTG 50 mg orally BID
* DTG 50 mg + 2 NRTI each morning (non-study)
* 2nd dose: DTG 50 mg each evening (during 3HP)
* 3HP: INH 900 mg + RPT 900 mg each week for 12 weeks Receives: Drug: Rifapentine; Drug: Isoniazid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Maternal all-cause mortality (both groups)
Measured: from study entry at Week 0 through post partum Week 24, to be reported at end of trial
Targeted serious adverse events (SAEs)
Premature discontinuation for toxicity or intolerance, Grade 3 or higher maternal bleeding, peripheral neuropathy, elevated LFTs), targeted pregnancy outcomes (fetal demise, stillbirth, preterm delivery (PTD) <32 weeks, birthweight (BW) <1500g, neonatal death <28 days of age), or permanent discontinuation due to toxicity (both groups)
Measured: from study entry at Week 0 through post partum Week 12, to be reported at end of trial
PK sampling of Dolutegravir - Cl/F parameter
Oral clearance in the presence or absence of 1HP or 3HP (both groups)
Measured: PK sampling at Week 1 (Day 1) and Week 3 (Day 17) for both groups, and at Week 8 (Day 52) for Group 2 (3HP arm), to be reported at end of trial
PK sampling of Dolutegravir - AUC parameter
Area under the plasma drug concentration-time curve (AUC) in the presence or absence of 1HP or 3HP (both groups)
Measured: PK sampling at Week 1 (Day 1) and Week 3 (Day 17) for both groups, and at Week 8 (Day 52) for Group 2 (3HP arm), to be reported at end of trial
PK sampling of Dolutegravir - Ctau parameter
Trough concentration (Ctau) in the presence or absence of 1HP or 3HP (both groups)
Measured: PK sampling at Week 1 (Day 1) and Week 3 (Day 17) for both groups, and at Week 8 (Day 52) for Group 2 (3HP arm), to be reported at end of trial
Secondary outcomes (14)
HIV-1 RNA viral load- maternal
Maternal HIV-1 RNA viral load (copies/ml) (both groups)
Measured: HIV viral load to be measured at Screening, Week 3, at Delivery, and post partum Week 12, to be reported at end of trial
DTG Dose selection
Dose options for DTG with 1HP or 3HP derived by simulation using nonlinear mixed effects models (both groups)
Measured: Dose selection will be determined at the interim analysis to be conducted when 25 participants from Arms 1 and 2 respectively have completed the Week 3 PK visit. Based upon these results, new enrollees will receive DTG either once or twice daily.
PK sampling of RPT - AUC parameter
Area under curve (AUC) in participants taking 1HP (Group 1)
Measured: PK sampling at Week 3 (Day 17 ) to be reported at end of trial
PK sampling of RPT - Ctau parameter
Trough concentration (Ctau) in participants taking 1HP (Group 1)
Measured: PK sampling at Week 3 (Day 17 ) to be reported at end of trial
Adverse Events- maternal
Grade 3 or higher maternal adverse events (AE) (all groups)
Measured: from study entry at Week 0 through post partum Week 12, to be reported at end of trial
Adverse Events- pregnancy
Grade 3 or higher pregnancy adverse events (AE) (all groups)
Measured: from study entry at Week 0 through post partum Week 12, to be reported at end of trial
Adverse Events- infant
Grade 3 or higher infant adverse events (AE) (all groups)
Measured: from Delivery through post partum Week 24, to be reported at end of trial
HIV infection- infant
Infant HIV infection (all groups)
Measured: from Delivery through post partum Week 24, to be reported at end of trial
Infant growth parameters- HAZ
Height-for-age z-score (all groups)
Measured: from Delivery through post partum Week 24, to be reported at end of trial
Infant growth parameters- WAZ
Weight-for-age z-score (WAZ) (all groups)
Measured: from Delivery through post partum Week 24, to be reported at end of trial
Infant growth parameters- HCAZ
Head circumference-for-age z-score (HCAZ) (all groups)
Measured: from Delivery through post partum Week 24, to be reported at end of trial
TB disease-maternal
confirmed maternal TB disease (all groups)
Measured: from study entry at Week 0 through post partum Week 24, to be reported at end of trial
TB disease-infant
confirmed or suspected infant TB disease (all groups)
Measured: from Delivery through post partum Week 24, to be reported at end of trial
Treatment adherence- HP
Proportion of doses taken for 1HP and 3HP regimens
Measured: from study entry at Week 0 through up to 8 weeks of 1HP (Group 1) or up to 16 weeks of 3HP (Group 2) , to be reported at end of trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start17 Jan 2024
- Primary completion24 Oct 2025
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV SeropositivityStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized 1:1 to receive either 1HP or 3HP
- Masking
- None (open label)
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Aurum Institute NPC
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, Weill Medical College of Cornell University, University of Washington
- Responsible party
- Sponsor
- Investigators
- Dr Vaneshree Govender, Principal investigator, Aurum Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05122026
- Sponsor's protocol ID
- IRB00299011
- Other IDs
- 3HP-MOMS-AUR1-6-351
- Acronym
- DOLPHIN Moms
- Status last verified
- Dec 2025
- First submitted
- 26 Oct 2021
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability of 1 Month Daily (1HP) and 3 Months Weekly (3HP) Isoniazid and Rifapentine With Pharmacokinetics of Dolutegravir (DTG) in Pregnant People With HIV
- ClinicalTrials.gov ID
- NCT05122026
- Acronym / sponsor ID
- DOLPHIN Moms / IRB00299011
- Conditions
- HIV Seropositivity, Pregnancy, Tuberculosis Infection
- Keywords
- Dolutegravir, 3HP, Rifapentine, pharmacokinetic, TB preventive treatment
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- The Aurum Institute NPCUniversity, hospital or other
- Collaborators
- Johns Hopkins University, Weill Medical College of Cornell University, University of Washington
- Study start
- 17 Jan 2024 (actual)
- Primary completion
- 24 Oct 2025 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Nov 2021 (actual)
- 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.
Open-label, two-arm, randomized multicenter study to investigate the safety, tolerability, and pharmacokinetics (PK), and potential interactions between dolutegravir (DTG) and rifapentine (RPT) during pregnancy in people with HIV when RPT is given with isoniazid (INH) daily for 4 weeks (1HP) or weekly for 3 months (3HP) as part of tuberculosis (TB) preventive therapy (TPT). Adults (age ≥18) who are pregnant with a singleton pregnancy (confirmed by ultrasound) at a gestational age of 20-34 weeks and virally suppressed on an existing DTG-based plus two nucleoside reverse transcriptase inhibitors (NRTI) antiretroviral (ART) regimen for at least four weeks may participate.
Detailed description
Enrolled participants will be randomized 1:1 to Arms 1 and 2.
Arm 1: 1HP (n=126):
Participants will start twice-daily DTG on Day 0, and will receive once-daily HP for 28 total doses, starting on Day 1. HIV viral load (VL) will be measured at baseline (screening), week 3 (Day 17), at delivery, and post-partum week 12. Safety labs: complete blood count (CBC), urea and electrolytes (U\&E), creatinine, prothrombin time and international normalized ratio (PT/INR), and liver function tests (LFT) will be obtained at screening for everyone and at follow-up visits, if clinically indicated; CBCs and LFTs will be checked at delivery in all participants.
The first 25 participants enrolled to Arm 1 who consent to be in a PK substudy will participate in sparse PK blood collections for DTG. Sparse PK sampling for DTG will be performed on the morning of Day 1, before starting 1HP and before the morning dose of DTG. Additional sparse PK sampling for DTG will be performed prior to DTG dosing on Day 17 (to track with 72 hours after the 3rd dose of HP in Arm 2).
A plasma specimen for RPT PK will also be collected on Day 17.
Arm 2: 3HP (n=126):
Participants will start twice-daily DTG on Day 0, and will receive once-weekly HP for 12 total doses starting on Day 1. HIV VL will be measured at baseline (screening), week 3 (Day 17), at delivery, and at post-partum week 12. Safety labs: CBC, U\&E, creatinine, PT/INR, and LFTs will be obtained at screening for everyone and at follow-up visits, if clinically indicated; CBCs and LFTs will be drawn at delivery.
The first 25 participants enrolled to Arm 2 who consent to be in a PK substudy will participate in sparse PK blood collections for DTG. Sparse PK sampling for DTG will be performed on the morning of Day 1, before starting 3HP, and before the morning dose of DTG. Additional sparse PK sampling for DTG will be performed on Day 17 prior to DTG dosing (72 hours after the 3rd dose of HP) and on Day 52 prior to DTG dosing (72 hours after the 8th dose of HP).
There will not be plasma collection on Day 17 for RPT PK in Arm 2, because specimen collection would be 72 hours after the weekly HP dose and a RPT level will likely not be detectable.
Interim analysis will occur when 25 participants each from Arms 1 and 2 have completed the Week 3 (Day 17) sparse PK visit. Ongoing enrolment will not be paused during the interim analysis, which will assess DTG PK, safety, and VL data.
Enrollment will be paused if accrual to each arm reaches 101 participants before the interim analysis has been completed. Once results are available, then enrollment will restart with dosing (daily vs. BID) based on the DTG PK results.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized 1:1 to receive either 1HP or 3HP
| Arm | Type | Receives |
|---|---|---|
| Arm 1: One month of daily isoniazid and rifapentine (4 weeks) | Experimental | Drug: Rifapentine, Drug: Isoniazid* DTG 50 mg orally BID * DTG 50 mg + 2 NRTI each morning (non-study) * 2nd dose: DTG 50 mg each evening (during 1HP) * 1HP: INH 300 mg + RPT 600 mg each morning for 4 weeks |
| Arm 2: Three months of once-weekly isoniazid and rifapentine (12 weeks) | Experimental | Drug: Rifapentine, Drug: Isoniazid* DTG 50 mg orally BID * DTG 50 mg + 2 NRTI each morning (non-study) * 2nd dose: DTG 50 mg each evening (during 3HP) * 3HP: INH 900 mg + RPT 900 mg each week for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age > 18 years
- Weight > 50 kg
- Documented HIV infection
- At least 4 weeks of ART and virally suppressed on dolutegravir plus two NRTIs
- Undetectable HIV-1 viral load
Key exclusion criteria (15 listed)
- Confirmed or suspected TB disease
- Likely to move from the study area during the study period
- Known exposure to pulmonary TB cases with known or suspected resistance to isoniazid or rifampicin in the source case
- TB treatment within the past year
- TB preventive therapy within the last year
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 |
|---|---|---|
| RifapentineAlso: PriftinAs included in arm/group description | Drug | Arm 1: One month of daily isoniazid and rifapentine (4 weeks), Arm 2: Three months of once-weekly isoniazid and rifapentine (12 weeks) |
| IsoniazidAlso: Winthrop IsoniazidAs included in arm/group description | Drug | Arm 1: One month of daily isoniazid and rifapentine (4 weeks), Arm 2: Three months of once-weekly isoniazid and rifapentine (12 weeks) |
Primary outcome
Mortality
Time frame: from study entry at Week 0 through post partum Week 24, to be reported at end of trial
Maternal all-cause mortality (both groups)
Targeted serious adverse events (SAEs)
Time frame: from study entry at Week 0 through post partum Week 12, to be reported at end of trial
Premature discontinuation for toxicity or intolerance, Grade 3 or higher maternal bleeding, peripheral neuropathy, elevated LFTs), targeted pregnancy outcomes (fetal demise, stillbirth, preterm delivery (PTD) <32 weeks, birthweight (BW) <1500g, neonatal death <28 days of age), or permanent discontinuation due to toxicity (both groups)
PK sampling of Dolutegravir - Cl/F parameter
Time frame: PK sampling at Week 1 (Day 1) and Week 3 (Day 17) for both groups, and at Week 8 (Day 52) for Group 2 (3HP arm), to be reported at end of trial
Oral clearance in the presence or absence of 1HP or 3HP (both groups)
PK sampling of Dolutegravir - AUC parameter
Time frame: PK sampling at Week 1 (Day 1) and Week 3 (Day 17) for both groups, and at Week 8 (Day 52) for Group 2 (3HP arm), to be reported at end of trial
Area under the plasma drug concentration-time curve (AUC) in the presence or absence of 1HP or 3HP (both groups)
PK sampling of Dolutegravir - Ctau parameter
Time frame: PK sampling at Week 1 (Day 1) and Week 3 (Day 17) for both groups, and at Week 8 (Day 52) for Group 2 (3HP arm), to be reported at end of trial
Trough concentration (Ctau) in the presence or absence of 1HP or 3HP (both groups)
14 secondary outcomes
HIV-1 RNA viral load- maternal
Time frame: HIV viral load to be measured at Screening, Week 3, at Delivery, and post partum Week 12, to be reported at end of trial
DTG Dose selection
Time frame: Dose selection will be determined at the interim analysis to be conducted when 25 participants from Arms 1 and 2 respectively have completed the Week 3 PK visit. Based upon these results, new enrollees will receive DTG either once or twice daily.
PK sampling of RPT - AUC parameter
Time frame: PK sampling at Week 3 (Day 17 ) to be reported at end of trial
PK sampling of RPT - Ctau parameter
Time frame: PK sampling at Week 3 (Day 17 ) to be reported at end of trial
Adverse Events- maternal
Time frame: from study entry at Week 0 through post partum Week 12, to be reported at end of trial
Adverse Events- pregnancy
Time frame: from study entry at Week 0 through post partum Week 12, to be reported at end of trial
Adverse Events- infant
Time frame: from Delivery through post partum Week 24, to be reported at end of trial
HIV infection- infant
Time frame: from Delivery through post partum Week 24, to be reported at end of trial
Infant growth parameters- HAZ
Time frame: from Delivery through post partum Week 24, to be reported at end of trial
Infant growth parameters- WAZ
Time frame: from Delivery through post partum Week 24, to be reported at end of trial
Infant growth parameters- HCAZ
Time frame: from Delivery through post partum Week 24, to be reported at end of trial
TB disease-maternal
Time frame: from study entry at Week 0 through post partum Week 24, to be reported at end of trial
TB disease-infant
Time frame: from Delivery through post partum Week 24, to be reported at end of trial
Treatment adherence- HP
Time frame: from study entry at Week 0 through up to 8 weeks of 1HP (Group 1) or up to 16 weeks of 3HP (Group 2) , to be reported at end of trial
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Dr Vaneshree Govender principal investigator
Aurum Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Rifapentine and Isoniazid in people with HIV Seropositivity and Pregnancy, run by The Aurum Institute NPC at 3 sites in South Africa.
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 7 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Africa. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: from study entry at Week 0 through post partum Week 24, to be reported at end of trial). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Dec 2025.