Could a simpler HIV pill protect moms and babies?
NCT ID NCT07616739
First seen Jun 26, 2026 · Last updated Sep 18, 2026 · Updated 2 times
Summary
This study will test a two-drug HIV pill (Dolutegravir/Lamivudine) in 210 pregnant women who have never taken HIV medication. The goal is to see if it controls the virus and prevents passing HIV to their babies. Participants will be compared to those on standard three-drug therapy. The study will also monitor side effects and birth outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Dolutegravir/Lamivudine (a two-drug HIV pill)
- What this could lead to
- If successful, this could show that a simpler two-drug regimen is safe and effective for pregnant women with HIV, reducing the risk of passing the virus to their babies.
- What could go wrong
- This is a Phase 4 study, so the drugs are already approved, but results may not apply to all populations. There is a risk of side effects or the two-drug combo being less effective than standard three-drug therapy.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 210 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2026
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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15 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: All persons who are eligible must meet all of the following: 1. Confirmed HIV-1 infection: All tests must use blood, serum, or plasma samples. Documentation may be obtained from medical records. HIV-1 positive is defined as having HIV-1 RNA in plasma ≥ 1000 copies/mL, plus one antibody test or two positive HIV antibody tests (two different rapid tests or one rapid test and one positive ELISA/EIE test). If any of these diagnostic test results are not available, they will be performed at the SCR visit. In all cases, an HIV viral load test will be performed. 2. Not exposed to prior antiretroviral therapy (ART): No prior antiretroviral therapy, including exposure to PrEP and/or PEP in the last 6 months. 3. Ability to sign the informed consent form. 4. Plasma HIV-1 RNA ≥1000 copies/mL. Viral load from the last 30 days may be valid. . Age ≥ 16 years or older in Argentina, ≥ 15 years or older in Brazil. The participant must be of the age required in their country of residence to give legal informed consent. Otherwise, informed consent must be signed by a parent or legal guardian, according to country guidelines, in addition to the participant. 6\. Pregnant at any gestational age up to 32 weeks at the time of the screening visit: Viable pregnancy with a gestational age ≤32 weeks, defined according to menstrual history and/or ultrasound. Note: If the menstrual history is unknown or if there is a discrepancy between the menstrual history and the ultrasound, the gestational age will be determined based on the best technology available at each center. 7\. The participant intends to continue with the pregnancy. Exclusion Criteria: All eligible individuals must NOT meet any of the following criteria: 1. Documented resistance to 3TC (presence of the M184V/I mutation) or DTG (defined as the presence of G118R, Q148 H/K/R, or R263K). 2. Active hepatitis C infection. 3. Active hepatitis B (HBsAg positive or detectable HBV viral load in cases with isolated positive HBV anti-core). 3. Hemoglobin \<8 g/dL. 4. Fetal abnormalities detected on ultrasound 5. Concomitant medications required with possible drug interactions specified in section 5.10. 6. ALT \>=5 times the ULN, or ALT \>=3xULN and bilirubin \>=1.5xULN (with \>35% direct bilirubin). Participants with severe hepatic impairment (Class C) as determined by Child-Pugh classification 7. Presence of severe preeclampsia or other pregnancy-related events, in current or previous pregnancies, such as renal or hepatic abnormalities (grade 2 or higher proteinuria, elevated serum creatinine, CrCl \<50 mL/min, total bilirubin, ALT, or AST). 8. Active opportunistic infection at screening: active severe opportunistic infections and/or severe bacterial infection, including active tuberculosis or severe disease or unstable clinical condition within 14 days prior to study entry. 9. Any patient or disease-related condition that, in the investigator's opinion, would prevent the patient from adhering to study medication or complying with study visits or procedures. 10. Problematic drug and/or alcohol use, which in the opinion of the site investigator could interfere with therapeutic compliance with study requirements. 11. Known allergy or sensitivity to any of the study medications or their formulations. 12. Vomiting or any other reason generating inability to swallow medications due to a pre-existing active disorder that prevents proper swallowing and absorption of study medications. 13. Creatinine Clearance of \<30 mL/min . If a creatinine value was obtained within 30 days prior to the screening visit, it may be used to calculate the CrCl.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
10 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Complexo do Hospital de Clínicas da UFPR/Ebserh
NOT_YET_RECRUITINGCuritiba, Pernambuco, 80430-000, Brazil
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Fundação Bahiana de Infectologia
NOT_YET_RECRUITINGSalvador, Estado de Bahia, 40110-160, Brazil
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Hospital General de Agudos Dr. Cosme Argerich
RECRUITINGCiudad Autónoma de Buenos Aires, Buenos Aires, C1155AHD, Argentina
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Hospital Geral de Nova Iguaçu
NOT_YET_RECRUITINGNova Iguaçu, Rio de Janeiro, 26030-380, Brazil
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Hospital Nacional Profesor Alejandro Posadas
NOT_YET_RECRUITINGEl Palomar, Buenos Aires, B1684, Argentina
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Hospital de Agudos J.A. Fernandez
RECRUITINGCiudad Autónoma de Buenos Aires, Buenos Aires, C1425AGP, Argentina
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Hospital de Agudos Paroissien
NOT_YET_RECRUITINGIsidro Casanova, Buenos Aires, B1765, Argentina
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RDSS - Ricardo Sobhie Diaz & Cia Solucoes Cientificas Ltda - Ricardo Diaz Scientific Solution
NOT_YET_RECRUITINGSão Paulo, 04037-030, Brazil
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Sanatorio Güemes
RECRUITINGCiudad Autónoma de Buenos Aires, Buenos Aires, C1188AAF, Argentina
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Universidade Federal do Rio Grande do Norte
NOT_YET_RECRUITINGNatal, Rio Grande do Norte, 59075-070, Brazil
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