DTG Plus 3TC for Prophylaxis of Mother-to-child Transmission of HIV Infection in Pregnant Women

NCT04808973 | Completed Phase 3 DMC

• 1 other identifier: 213477
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to evaluate the safety and efficacy of a 2 drugs ART regimen (lamivudine plus dolutegravir) for prevention of mother to child transmission in pregnant women with HIV. 20 pregnant women will be enrolled in this proof of concept protocol. They will be prescribed DTG-3TC (fixed-dose combination), and will be followed up to the end of gestation. Initially, a total of 10 pregnant women will be recruited for the first phase of the study. Once the first phase is successfully completed, 10 additional participants will be included in a second step.

Conditions

HIV Infections; Pregnancy Related; Mother to Child Transmission

Keywords

HIV; Pregnant women; MTCT

Outcome Measures

Primary Outcomes (1)

• undetectable HIV-1 plasma viral load at delivery

  proportion of women achieving a plasma HIV RNA viral load below 50 copies at delivery

  6 months

Secondary Outcomes (2)

• switch fo therapy up to delivery

  6 months

• frequency of adverse events for mothers and babies

  8 months

Study Arms (1)

Lamivudine plus Dolutegravir in FDC

EXPERIMENTAL

Single arm of 3TC+DTG for treatment of pregnant women with HIV infection

Drug: Dolutegravir plus lamivudine in a FDC

Interventions

Dolutegravir plus lamivudine in a FDC DRUG

All participants will receive an ART regimen composed by Lamivudine plus Dolutegravir in a single pill (FDC)

Lamivudine plus Dolutegravir in FDC

Eligibility Criteria

• Age: 15 Years+
• Gender Eligibility Details: only pregnant women will be included
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed HIV infection
• No previous exposure to ARV drugs
• Plasma viral load ≥1,000 copies/ml
• Gestational age ≥ 14 and ≤ 28 weeks (checked by ultrasound)
• Age ≥ 15 years

You may not qualify if:

• Presence of genotypic resistance mutations for 3TC or DTG
• Presence of active Hepatitis C
• Hepatitis B infection (a positive test for HBcore or HBsurface antibodies)
• Anemia (haemoglobin less than 8 g/dL);
• Need to use concomitant drugs with potentially relevant DDI, which require DTG dose adjustment (e.g., rifampin, carbamazepine, phenobarbital,phenytoin)
• Elevations in serum levels of alanine aminotransferase (ALT) greater than 5 times the upper limit of normal (ULN) or ALT \>3xULN and bilirubin \>1.5ULN (with \>35% direct bilirubin);
• A history or clinical suspicion of unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hyperbilirubinaemia, oesophageal or gastric varices or persistent jaundice);
• Subjects with severe hepatic impairment (Class C) as determined by Child-Pugh classification
• Presence of severe pre-eclampsia, or other pregnancy related events such as renal or liver abnormalities (grade 2 or above proteinuria, elevation in serum creatinine CrCl\<50 ml/min), total bilirubin, ALT or AST)

Sponsors & Collaborators

• Fundação Bahiana de Infectologia: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Fundação Bahiana de Infectologia

Salvador, Estado de Bahia, 40110160, Brazil

Location

MeSH Terms

Conditions

HIV Infections

Interventions

dolutegravir; Lamivudine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A group of 20 pregnant women will be enrolled, in two phases: the first one will include 10 women, and if no safety sign is detected after completion of this initial group, additional 10 women will be enrolled

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 22, 2021
• Study Start: July 1, 2021
• Primary Completion: August 31, 2023
• Study Completion: September 10, 2023
• Last Updated: October 4, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)