Dolutegravir/Lamivudine in treatment-naïve pregnant women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 4 interventional trial evaluates DTG/3TC (dolutegravir plus lamivudine) as first-line therapy in ART-naïve pregnant women with HIV. Primary endpoints include the proportion achieving HIV-1 RNA <200 copies/mL at delivery and assessing mother-to-child transmission through six months of age in exposed infants. Secondary endpoints cover maternal safety, perinatal outcomes, immune changes, resistance mutations, and safety/virological outcomes across comparator regimens (DTG+3TC vs DTG+TDF/FTC or DTG+TAF/FTC). The study uses intention-to-treat exposed analysis for virologic outcomes and collects data on weight gain, CD4/CD8 dynamics, and breastfeeding-related infection in children. Enrollment is conducted at select clinical centers in Argentina.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital General de Agudos Dr. Cosme Argerich
  Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina Recruiting
• Sanatorio Güemes
  Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina Recruiting
• Hospital de Agudos J.A. Fernandez
  Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina Recruiting
• Hospital Nacional Profesor Alejandro Posadas
  El Palomar, Buenos Aires, Argentina Not yet recruiting
• Hospital de Agudos Paroissien
  Isidro Casanova, Buenos Aires, Argentina Not yet recruiting
• Fundação Bahiana de Infectologia
  Salvador, Estado de Bahia, Brazil Not yet recruiting

Study contacts

• Principal investigator: Pedro Enrinque Cahn, MD — Fundación Huésped
• Study coordinator: María Inés Figueroa, MD
• Email: maria.figueroa@huesped.org.ar
• Phone: +541149817777

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.