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

• Status: Not yet recruiting
• Trial end date: 2023-01-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Fundação Bahiana de Infectologia
• Collaborator: GlaxoSmithKline
• Treatments: Dolutegravir; Lamivudine

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)