Safety and Efficacy of Fixed Dose Combination Dolutegravir/Abacavir/Lamivudine FDC Initiated Duri… (NCT02384395) | Clinical Trial Compass
CompletedNot Applicable
Safety and Efficacy of Fixed Dose Combination Dolutegravir/Abacavir/Lamivudine FDC Initiated During Acute HIV Infection
United States40 participantsStarted 2015-09
Plain-language summary
This is a multicenter, single arm, 96-week open-label study of the safety and virologic efficacy of fixed dose combination Dolutegravir/Lamivudine/Abacavir (DTG/3TC/ABC FDC) initiated during acute HIV infection (AHI).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Documentation of Acute HIV infection at or within 30 days of study entry.
✓. Men and women age ≥18 years.
✓. ART naive, defined as ≤14 days of antiretroviral treatment at any time prior to entry. The only exceptions are:
✓. Lab values obtained within 30 days prior to study entry:
✓. Testing for HBsAg is pending. Note: Participants who test positive for HBsAg will be terminated from the study prior to starting study treatment.
✓. Testing for HLA-B57 and/or HLA-B\*5701 is pending. Note: Participants who test positive for HLA-B\*5701 will be terminated from the study prior to starting study treatment.
✓. A female is eligible to enter and participate in the study if she:
✓. Females who meet the post-menopausal definition, noted in inclusion criterion 7, will have a follicle stimulation hormone (FSH) test to verify menopause,
Exclusion criteria
✕. Alanine Transaminase (ALT) ≥ 5 times Upper Limit of Normal (≥5xULN)
✕. Aspartate Aminotransferase (AST) ≥ 3x ULN
✕. Bilirubin ≥1.5x ULN (with \>35% direct bilirubin)
✕. Weight \<40 kg
✕
What they're measuring
1
Number of Participants With Viral Load Measurement <200 Copies/mL at Week 24