Status:
COMPLETED
DTG Plus 3TC for Prophylaxis of Mother-to-child Transmission of HIV Infection in Pregnant Women
Lead Sponsor:
Fundação Bahiana de Infectologia
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
HIV Infections
Pregnancy Related
Eligibility:
FEMALE
15+ years
Phase:
PHASE3
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 ...
Detailed Description
Main endpoints: Primary: -Proportion of women with undetectable HIV-1 plasma viral load at delivery Secondary: * Proportion of women switching therapy up to delivery * Frequency of adverse events,...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 10 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04808973
Start Date
July 1 2021
End Date
September 10 2023
Last Update
October 4 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fundação Bahiana de Infectologia
Salvador, Estado de Bahia, Brazil, 40110160