HIV-1-infectionPhase 4PREDUALNCT07616739
Dolutegravir/Lamivudine in Treatment-Naïve Pregnant Women
A Phase 4 study testing Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet [DOVATO] and TDF/XTC or TAF/FTC plus Dolutegravir (XTC stand for lamivudine OR emtricitabine) in people with HIV-1-infection, run by Fundación Huésped at 10 sites in 2 countries.
Trial summary
Protocol Number: FH-94 Study Objetives: Primary: To evaluate the virological response to Dolutegravir/Lamivudine in naive pregnant women with HIV who are starting antiretroviral therapy and vertical transmission in exposed neonates. Secondary: To evaluate the incidence of maternal adverse events. Read more about this study
- Who is it for?
- Ages 15 years and older, women only
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet [DOVATO] and TDF/XTC or TAF/FTC plus Dolutegravir (XTC stand for lamivudine OR emtricitabine)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 10 Sep 2026to 15 Oct 2028
- Phase
- Phase 4
- 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 15 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All persons who are eligible must meet all of the following:
- 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.
- Not exposed to prior antiretroviral therapy (ART): No prior antiretroviral therapy, including exposure to PrEP and/or PEP in the last 6 months.
- Ability to sign the informed consent form.
- 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.
Who cannot join
- All eligible individuals must NOT meet any of the following criteria:
- Documented resistance to 3TC (presence of the M184V/I mutation) or DTG (defined as the presence of G118R, Q148 H/K/R, or R263K).
- Active hepatitis C infection. 3. Active hepatitis B (HBsAg positive or detectable HBV viral load in cases with isolated positive HBV anti-core).
- Hemoglobin <8 g/dL.
- Fetal abnormalities detected on ultrasound
- Concomitant medications required with possible drug interactions specified in section 5.10.
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- 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
- 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).
- 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.
- 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.
- Problematic drug and/or alcohol use, which in the opinion of the site investigator could interfere with therapeutic compliance with study requirements.
- Known allergy or sensitivity to any of the study medications or their formulations.
- 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.
- 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.
Trial locations and contacts
10 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 2 countries
Argentina5 sites, 5 recruiting
- Recruiting
Hospital General de Agudos Dr. Cosme Argerich
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1155AHD
Diego Cecchini, MD, +54911 54976263, diegocec@gmail.com
Diego Cecchini, MD
- Recruiting
Sanatorio Güemes
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1188AAF
Verónica Lacal, MD, +54 9 11 58296259, verolacal@gmail.com
Sebastián Nuñez, MD, +54 11 4959-8200 ext. 8384 / 8365, snunez@fsg.edu.ar
- Recruiting
Hospital de Agudos J.A. Fernandez
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1425AGP
María José Rolón, MD, +54 011 48082627, fernandez_infectologia@buenosaires.gob.ar
José MD, Barletta, +54 011 48082627, fernandez_infectologia@buenosaires.gob.ar
- Not yet recruiting
Hospital Nacional Profesor Alejandro Posadas
El Palomar, Buenos Aires, B1684
Mariana Golikow, MD, +54 9 11 3803-1126, marugolikow@gmail.com
Mariana Golikow, MD
- Not yet recruiting
Hospital de Agudos Paroissien
Isidro Casanova, Buenos Aires, B1765
Pablo Garnica, MD, +54 9 15-5958-4516, andrespablo451@hotmail.com
Eduardo Warley, MD, +54 011 1541897181, eduwarley@yahoo.com.ar
Brazil5 sites, 5 recruiting
- Not yet recruiting
Complexo do Hospital de Clínicas da UFPR/Ebserh
Curitiba, Pernambuco, 80430-000
Monica Maria Gomes da Silva, MD, 41-999951285, monica.gomez@ufpr.br
Monica Maria Gomes da Silva, MD
- Not yet recruiting
Universidade Federal do Rio Grande do Norte
Natal, Rio Grande do Norte, 59075-070
Monica Bay, MD, +55 84 994141921, monicabay@gmail.com
Monica Bay, MD
- Not yet recruiting
Hospital Geral de Nova Iguaçu
Nova Iguaçu, Rio de Janeiro, 26030-380
Aline Santos Ramalho Teixeira Benevenuto, MD, +55 21 35132812 ext. 295, alineramalhopesquisa@gmail.com
Aline Santos Ramalho Teixeira Benevenuto, MD
- Not yet recruiting
Fundação Bahiana de Infectologia
Salvador, Estado de Bahia, 40110-160
Carlos Brites, MD, +55 71 99232-9552, crbrites@gmail.com
Anne Kettley Lacerda de L. Gonzaga, RN, +55 (71) 3646-3561, annegonzaga.fbai@outlook.com
- Not yet recruiting
RDSS - Ricardo Sobhie Diaz & Cia Solucoes Cientificas Ltda - Ricardo Diaz Scientific Solution
São Paulo, 04037-030
Ricardo Sobhie Diaz, MD, +55(21)99799-4412, daniele.lunacunha@ricardodiaz.com.br
Ricardo Sobhie Diaz, MD
About this study
Official title: Evaluating the Efficacy and Safety of Dolutegravir/Lamivudine (DTG/3TC) in ART-Naïve Pregnant Women
Protocol Number: FH-94
Study Objetives:
Read more
Primary:
- To evaluate the virological response to Dolutegravir/Lamivudine in naive pregnant women with HIV who are starting antiretroviral therapy and vertical transmission in exposed neonates.
Secondary:
- To evaluate the incidence of maternal adverse events.
- To evaluate perinatal outcomes at delivery.
- To evaluate maximum virological suppression at delivery.
- To evaluate the incidence of changes in body weight exceeding what is expected for gestation.
- To evaluate the immune response based on changes in CD4, CD8, and CD4/CD8 ratio values during pregnancy.
- Assess baseline resistance and the development of resistance to virological failure to integrase inhibitors and INTRs during treatment with DTG+3TC or DTG+TDF/XTC or DTG+TAF/FTC.
- To evaluate the incidence of HIV infection in children that breastfeed.
- To evaluate safety outcomes and virological response of DTG+3TC compared to DTG+TDF/XTC or DTG+TAF/FTC.
Exploratory:
- To explore the non-inferiority of DTG+3TC therapy compared to DTG+TDF/XTC or DTG+TAF/FTC treatment.
- To evaluate the frequency of antiretroviral therapy withdrawal or modification before delivery.
Read the detailed description
Primary endpoints:
- Proportion of pregnant women who achieve an HIV-1 plasma viral load <200 copies/mL at delivery after starting DTG+3TC (Intention-to-Treat Exposed analysis).
- Proportion of children born without HIV infection at 6 weeks \& 6 months of age, defined by the negative result of negative virological tests (PCR) performed at birth (delivery visit and up to 72 hours after delivery), at 6 weeks, and at 6 months
Secondary endpoints:
- Frequency of grade 2 or higher maternal adverse events, by type and severity, from baseline to 6 months postpartum.
- Frequency of spontaneous abortion, preterm delivery, congenital malformations at birth or identified and reported during the first 6 month of life, or intrauterine fetal death.
- Proportion of pregnant women with plasma viral load below 50 copies/mL at delivery.
- Average total weight gain and BMI during pregnancy, compared with recommendations based on pre-pregnancy BMI.
- Changes in CD4 lymphocyte count and CD4/CD8 ratio between baseline and delivery visit values.
- Frequency and type of mutations according to the International AIDS Society (IAS-USA drug resistance mutations, 2025) mutation guidelines panel at the baseline visit and in case of virological failure at any time during the study.
- Proportion of HIV infection among breastfed children.
- Frequency of grade 2 or higher maternal adverse events, by type and severity, between the two arms. Frequency of pregnant women with plasma viral load <200 copies/mL in the two arms at delivery visit.
Exploratory endpoints:
- Difference in the proportion of pregnant women who achieve an HIV-1 plasma viral load of less than 50 copies/mL at delivery between the DTG+3TC and DTG+TDF/XTC or DTG+TAF/FTC groups, to explore the non-inferiority of the dual regimen.
- Proportion of participants requiring a change in antiretroviral regimen (due to lack of efficacy, adverse events, medical decision, or other reasons) before delivery.
Patient Population: HIV-1-infected Pregnant Women aged >16 years (>15 years for Brazil's sites) who are naïve to antiretroviral therapy Study design: Phase IV. Randomized, non-comparative, open-label, multicenter study.
Regimens: Dolutegravir 50 mg /lamivudine 300 mg QD FDC. Dolutegravir 50 mg QD plus tenofovir 300 mg/emtricitabine 200mg or plus tenofovir 300 mg/ lamivudine 300 mg or tenofovir alafenamide 25 mg/emtricitabine 200 mg.
Duration: 14 months approximately months (depending on gestational age at entry).
Sample size: 210 subjects
- Conditions
- HIV-1-infection
- Being tested
- Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet [DOVATO], TDF/XTC or TAF/FTC plus Dolutegravir (XTC stand for lamivudine OR emtricitabine)
- Keywords
- antiretroviral naive triple therapy, Dolutegravir-Lamivudine dual-therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet [DOVATO]Drug
Also called BI-THERAPY
1 pill QD
TDF/XTC or TAF/FTC plus Dolutegravir (XTC stand for lamivudine OR emtricitabine)Drug
Also called Triple therapy
1 pill of each QD
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Dolutegravir plus Lamivudine DOVATO: Dolutegravir 50mg/lamivudine 300 mg, FDC, 1 coformulated tablet QD Receives: Drug: Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet [DOVATO] |
| Active Comparator | Active comparator | TDF/XTC or TAF/FTC plus Dolutegravir (XTC stands for lamivudine OR emtricitabine)
* TDF/FTC 300/200 mg, 1 coformulated tablet QD (FDC) plus Dolutegravir 50 mg, 1 tablet QD OR
* TDF/3TC 300/300 mg, 1 coformulated tablet QD (FDC) plus Dolutegravir 50 mg, 1 tablet QD
* TAF/FTC 25/200 MG, 1 tablet QD (FDC) plus Dolutegravir 50 mg, 1 tablet QD Receives: Drug: TDF/XTC or TAF/FTC plus Dolutegravir (XTC stand for lamivudine OR emtricitabine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the virological response to Dolutegravir/Lamivudine in pregnant women with HIV who are starting antiretroviral therapy and vertical transmission in exposed neonates
Endpoints:
- Proportion of pregnant women who achieve an HIV-1 plasma viral load <200 copies/mL at delivery after starting DTG+3TC (Intention-to-Treat Exposed analysis).
- Proportion of children born without HIV infection at 6 weeks \& 6 months of age, defined by the negative result of negative virological tests (PCR) performed at birth (delivery visit and up to 72 hours after delivery), at 6 weeks, and at 6 months.
Measured: From enrollment to the end of treatment at 6 months after delivery
Secondary outcomes (9)
- To evaluate the incidence of adverse maternal events.
Frequency of grade 2 or higher maternal adverse events, by type and severity, from baseline to 6 months postpartum
Measured: From enrollment to the end of treatment at 6 months after delivery
- To evaluate perinatal outcomes at delivery
Frequency of spontaneous abortion, preterm delivery, congenital malformations at birth or identified and reported during the first 6 month of life, or intrauterine fetal death.
Measured: From enrollment to the end of treatment at 6 months after delivery
- To evaluate maximum virological suppression at delivery
Proportion of pregnant women with plasma viral load below 50 copies/mL at delivery.
Measured: From enrollment to the end of treatment at 6 months after delivery
- To evaluate the incidence of changes in body weight exceeding what is expected for gestation
Average total weight gain and BMI during pregnancy, compared with recommendations based on pre-pregnancy BMI.
Measured: From enrollment to the end of treatment at 6 months after delivery
- To evaluate the immune response based on changes in CD4, CD8, and CD4/CD8 ratio values during pregnancy.
Changes in CD4 lymphocyte count and CD4/CD8 ratio between baseline and delivery visit values.
Measured: From enrollment to the end of treatment at 6 months after delivery
- Assess baseline resistance and the development of resistance to virological failure to integrase inhibitors and INTRs during treatment with DTG+3TC, DTG+TDF/XTC or DTG+TAF/FTC.
Frequency and type of mutations according to the International AIDS Society (IAS-USA drug resistance mutations, 2025) mutation guidelines panel at the baseline visit and in case of virological failure at any time during the study.
Measured: From enrollment to the end of treatment at 6 months after delivery
- To evaluate the incidence of HIV infection in children that breastfeed.
Proportion of HIV infection among breastfed children
Measured: From enrollment to the end of treatment at 6 months after delivery
To evaluate safety outcomes and virological response of DTG+3TC compared to DTG+TDF/XTC or DTG+TAF/FTC. Part 1 of 2.
Frequency of grade 2 or higher maternal adverse events, by type and severity, between the two arms.
Measured: From enrollment to the end of treatment at 6 months after delivery
To evaluate safety outcomes and virological response of DTG+3TC compared to DTG+TDF/XTC or DTG+TAF/FTC. Part 2 of 2
Frequency of pregnant women with plasma viral load <200 copies/mL in the two arms at delivery visit
Measured: From enrollment to the end of treatment at 6 months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start10 Sep 2026
- Primary completion15 Oct 2028 (estimated)
- Study completion15 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Huésped
- Sponsor type
- University, hospital or other
- Collaborators
- ViiV Healthcare
- Responsible party
- Principal investigator, Maria Ines Figueroa, Fundación Huésped
- Investigators
- Pedro Enrinque Cahn, MD, Principal investigator, Fundación Huésped
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07616739
- Sponsor's protocol ID
- FH-94
- Acronym
- PREDUAL
- Status last verified
- May 2026
- First submitted
- 14 May 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy and Safety of Dolutegravir/Lamivudine (DTG/3TC) in ART-Naïve Pregnant Women
- ClinicalTrials.gov ID
- NCT07616739
- Acronym / sponsor ID
- PREDUAL / FH-94
- Conditions
- HIV-1-infection
- Keywords
- antiretroviral naive triple therapy, Dolutegravir-Lamivudine dual-therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Fundación HuéspedUniversity, hospital or other
- Collaborators
- ViiV Healthcare
- Study start
- 10 Sep 2026 (actual)
- Primary completion
- 15 Oct 2028 (estimated)
- Study completion
- 15 Oct 2028 (estimated)
- First posted
- 1 Jun 2026 (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.
Protocol Number: FH-94
Study Objetives:
Primary:
- To evaluate the virological response to Dolutegravir/Lamivudine in naive pregnant women with HIV who are starting antiretroviral therapy and vertical transmission in exposed neonates.
Secondary:
- To evaluate the incidence of maternal adverse events.
- To evaluate perinatal outcomes at delivery.
- To evaluate maximum virological suppression at delivery.
- To evaluate the incidence of changes in body weight exceeding what is expected for gestation.
- To evaluate the immune response based on changes in CD4, CD8, and CD4/CD8 ratio values during pregnancy.
- Assess baseline resistance and the development of resistance to virological failure to integrase inhibitors and INTRs during treatment with DTG+3TC or DTG+TDF/XTC or DTG+TAF/FTC.
- To evaluate the incidence of HIV infection in children that breastfeed.
- To evaluate safety outcomes and virological response of DTG+3TC compared to DTG+TDF/XTC or DTG+TAF/FTC.
Exploratory:
- To explore the non-inferiority of DTG+3TC therapy compared to DTG+TDF/XTC or DTG+TAF/FTC treatment.
- To evaluate the frequency of antiretroviral therapy withdrawal or modification before delivery.
Detailed description
Primary endpoints:
- Proportion of pregnant women who achieve an HIV-1 plasma viral load <200 copies/mL at delivery after starting DTG+3TC (Intention-to-Treat Exposed analysis).
- Proportion of children born without HIV infection at 6 weeks \& 6 months of age, defined by the negative result of negative virological tests (PCR) performed at birth (delivery visit and up to 72 hours after delivery), at 6 weeks, and at 6 months
Secondary endpoints:
- Frequency of grade 2 or higher maternal adverse events, by type and severity, from baseline to 6 months postpartum.
- Frequency of spontaneous abortion, preterm delivery, congenital malformations at birth or identified and reported during the first 6 month of life, or intrauterine fetal death.
- Proportion of pregnant women with plasma viral load below 50 copies/mL at delivery.
- Average total weight gain and BMI during pregnancy, compared with recommendations based on pre-pregnancy BMI.
- Changes in CD4 lymphocyte count and CD4/CD8 ratio between baseline and delivery visit values.
- Frequency and type of mutations according to the International AIDS Society (IAS-USA drug resistance mutations, 2025) mutation guidelines panel at the baseline visit and in case of virological failure at any time during the study.
- Proportion of HIV infection among breastfed children.
- Frequency of grade 2 or higher maternal adverse events, by type and severity, between the two arms. Frequency of pregnant women with plasma viral load <200 copies/mL in the two arms at delivery visit.
Exploratory endpoints:
- Difference in the proportion of pregnant women who achieve an HIV-1 plasma viral load of less than 50 copies/mL at delivery between the DTG+3TC and DTG+TDF/XTC or DTG+TAF/FTC groups, to explore the non-inferiority of the dual regimen.
- Proportion of participants requiring a change in antiretroviral regimen (due to lack of efficacy, adverse events, medical decision, or other reasons) before delivery.
Patient Population: HIV-1-infected Pregnant Women aged >16 years (>15 years for Brazil's sites) who are naïve to antiretroviral therapy Study design: Phase IV. Randomized, non-comparative, open-label, multicenter study.
Regimens: Dolutegravir 50 mg /lamivudine 300 mg QD FDC. Dolutegravir 50 mg QD plus tenofovir 300 mg/emtricitabine 200mg or plus tenofovir 300 mg/ lamivudine 300 mg or tenofovir alafenamide 25 mg/emtricitabine 200 mg.
Duration: 14 months approximately months (depending on gestational age at entry).
Sample size: 210 subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet [DOVATO]Dolutegravir plus Lamivudine DOVATO: Dolutegravir 50mg/lamivudine 300 mg, FDC, 1 coformulated tablet QD |
| Active Comparator | Active comparator | Drug: TDF/XTC or TAF/FTC plus Dolutegravir (XTC stand for lamivudine OR emtricitabine)TDF/XTC or TAF/FTC plus Dolutegravir (XTC stands for lamivudine OR emtricitabine) * TDF/FTC 300/200 mg, 1 coformulated tablet QD (FDC) plus Dolutegravir 50 mg, 1 tablet QD OR * TDF/3TC 300/300 mg, 1 coformulated tablet QD (FDC) plus Dolutegravir 50 mg, 1 tablet QD * TAF/FTC 25/200 MG, 1 tablet QD (FDC) plus Dolutegravir 50 mg, 1 tablet QD |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- Not exposed to prior antiretroviral therapy (ART): No prior antiretroviral therapy, including exposure to PrEP and/or PEP in the last 6 months.
- Ability to sign the informed consent form.
- 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.
Key exclusion criteria (14 listed)
- Documented resistance to 3TC (presence of the M184V/I mutation) or DTG (defined as the presence of G118R, Q148 H/K/R, or R263K).
- Active hepatitis C infection. 3. Active hepatitis B (HBsAg positive or detectable HBV viral load in cases with isolated positive HBV anti-core).
- Hemoglobin <8 g/dL.
- Fetal abnormalities detected on ultrasound
- Concomitant medications required with possible drug interactions specified in section 5.10.
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 |
|---|---|---|
| Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet [DOVATO]Also: BI-THERAPY1 pill QD | Drug | Experimental |
| TDF/XTC or TAF/FTC plus Dolutegravir (XTC stand for lamivudine OR emtricitabine)Also: Triple therapy1 pill of each QD | Drug | Active Comparator |
Primary outcome
To evaluate the virological response to Dolutegravir/Lamivudine in pregnant women with HIV who are starting antiretroviral therapy and vertical transmission in exposed neonates
Time frame: From enrollment to the end of treatment at 6 months after delivery
Endpoints: * Proportion of pregnant women who achieve an HIV-1 plasma viral load <200 copies/mL at delivery after starting DTG+3TC (Intention-to-Treat Exposed analysis). * Proportion of children born without HIV infection at 6 weeks \& 6 months of age, defined by the negative result of negative virological tests (PCR) performed at birth (delivery visit and up to 72 hours after delivery), at 6 weeks, and at 6 months.
9 secondary outcomes
- To evaluate the incidence of adverse maternal events.
Time frame: From enrollment to the end of treatment at 6 months after delivery
- To evaluate perinatal outcomes at delivery
Time frame: From enrollment to the end of treatment at 6 months after delivery
- To evaluate maximum virological suppression at delivery
Time frame: From enrollment to the end of treatment at 6 months after delivery
- To evaluate the incidence of changes in body weight exceeding what is expected for gestation
Time frame: From enrollment to the end of treatment at 6 months after delivery
- To evaluate the immune response based on changes in CD4, CD8, and CD4/CD8 ratio values during pregnancy.
Time frame: From enrollment to the end of treatment at 6 months after delivery
- Assess baseline resistance and the development of resistance to virological failure to integrase inhibitors and INTRs during treatment with DTG+3TC, DTG+TDF/XTC or DTG+TAF/FTC.
Time frame: From enrollment to the end of treatment at 6 months after delivery
- To evaluate the incidence of HIV infection in children that breastfeed.
Time frame: From enrollment to the end of treatment at 6 months after delivery
To evaluate safety outcomes and virological response of DTG+3TC compared to DTG+TDF/XTC or DTG+TAF/FTC. Part 1 of 2.
Time frame: From enrollment to the end of treatment at 6 months after delivery
To evaluate safety outcomes and virological response of DTG+3TC compared to DTG+TDF/XTC or DTG+TAF/FTC. Part 2 of 2
Time frame: From enrollment to the end of treatment at 6 months after delivery
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 18 Sep 2026.
- Individual participant dataSharing planned: Yes
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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.
Pedro Enrinque Cahn, MD principal investigator
Fundación Huésped
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet [DOVATO] and TDF/XTC or TAF/FTC plus Dolutegravir (XTC stand for lamivudine OR emtricitabine) in people with HIV-1-infection, run by Fundación Huésped at 10 sites in 2 countries.
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 14 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: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Argentina, Brazil. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact María Inés Figueroa, MD (+541149817777, maria.figueroa@huesped.org.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the virological response to Dolutegravir/Lamivudine in pregnant women with HIV who are starting antiretroviral therapy and vertical transmission in exposed neonates (time frame: From enrollment to the end of treatment at 6 months after delivery). 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 18 Sep 2026.