Status:
COMPLETED
Dolutegravir Antiretroviral Strategy to Promote Improvement and Reduce Drug Exposure
Lead Sponsor:
Babafemi Taiwo
Collaborating Sponsors:
ViiV Healthcare
Conditions:
HIV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
HIV-1 infected subjects with CD4 nadir \> 200 cells/mm3, no history of virologic failure and plasma HIV RNA \<50 copies/mL for at least 48 weeks while on any United States Department of Health and Hum...
Detailed Description
DESIGN HIV-1 infected subjects with CD4 nadir \> 200 cells/mm3, no history of virologic failure and plasma HIV RNA \<50 copies/mL for at least 48 weeks while on any United States Department of Health ...
Eligibility Criteria
Inclusion
- HIV-1 Infection
- HIV-1 RNA \<50 copies/mL on all measurements within 48 weeks prior to study entry while on any DHHS recommended or alternative three-drug antiretroviral regimen. (A history of switching for simplification and/or tolerability is allowed. At least two measurements within the previous 48 weeks are required prior to study screening.)
- No history of virologic failure, defined as consecutive HIV RNA \> 50 copies/mL after 12 months of initiating ART. An isolated (non-consecutive) HIV RNA \> 50 copies/mL (but less than 400 copies/mL) is permitted after 12 months of initiating ART but not in the 48-week window prior to study entry.
- Screening plasma HIV RNA \< 20 copies/mL using the COBAS AmpliPrep/COBAS TaqMan HIV-1 Test V2.0, obtained within 45 days prior to study entry
- Nadir CD4 count \>200 cells/mm
- Pretreatment genotype documenting no mutations in the protease or reverse transcriptase genes
- No known resistance to integrase inhibitors
- Laboratory values obtained within 45 days prior to study entry:
- ANC \>750 Hemoglobin \>10 g/dL Platelets \>50,000 Calculated creatinine clearance (CrCl) \>50 mL/min
- Negative serum or urine pregnancy test
- Men and women age greater or equal to 18 years.
- Ability to continue current regimen (i.e, have uninterrupted access)
- No evidence of chronic hepatitis B
Exclusion
- Serious illness or AIDS-related complication within 21 days of screening requiring systemic treatment and/or hospitalization
- Treatment within 30 days prior to study entry with immune modulators
- Vaccination within 7 days
- Active HCV treatment or anticipated need for treatment within study period. (HCV infection alone is not exclusionary)
- Unstable liver disease or severe hepatic impairment
- Known allergy or hypersensitivity to DTG or lamivudine.
- Active drug or alcohol use or dependence that could interfere with adherence to study requirements
- ALT (alanine aminotransferase) \>5 x ULN (upper limit of normal) OR ALT \>3 x ULN and total bilirubin \>1.5 x ULN (with 35% direct bilirubin)
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2017
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT02263326
Start Date
December 1 2014
End Date
September 1 2017
Last Update
October 14 2019
Active Locations (7)
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1
University of California San Diego
San Diego, California, United States
2
Emory University
Atlanta, Georgia, United States
3
Northwestern University
Chicago, Illinois, United States, 60611
4
Brigham and Women's Hospital
Boston, Massachusetts, United States