Dolutegravir Antiretroviral Strategy to Promote Improvement and Reduce Drug Exposure
ASPIRE
1 other identifier
interventional
89
1 country
7
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 Human Services (DHHS) recommended or alternative three-drug antiretroviral regimen will be randomized to dolutegravir (DTG) plus lamivudine (Arm 1) or continuation of their current regimen (Arm 2) for 48 weeks. The primary endpoint is virologic failure defined as confirmed plasma HIV-1 RNA \> 50 copies/mL before or at Week 24
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Dec 2014
Typical duration for phase_3
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 6, 2014
CompletedFirst Posted
Study publicly available on registry
October 13, 2014
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedResults Posted
Study results publicly available
November 13, 2018
CompletedOctober 14, 2019
October 1, 2019
2.6 years
October 6, 2014
August 24, 2018
October 10, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of Participants With Treatment Failure
Proportion of participants with treatment failure (defined as virologic failure (HIV RNA \>50 copies/mL), loss to follow-up, or treatment discontinuation) between those who switch to DTG + lamivudine and those who continue their current ART regimen
24 weeks
Secondary Outcomes (6)
Proportion of Participants With Virologic Success
48 weeks
Change in CD4 Count From Baseline to Week 48
Baseline and 48 weeks
Change in Total Cholesterol From Baseline to Week 48
Baseline and 48 weeks
Change in LDL Cholesterol From Baseline to Week 48
Baseline and Week 48
Change in Creatinine Clearance From Baseline to Week 48
Baseline and Week 48
- +1 more secondary outcomes
Other Outcomes (1)
Residual Viremia by HIV-1 Single-copy Assay
48 weeks
Study Arms (2)
dolutegravir plus lamivudine
EXPERIMENTALdolutegravir 50 mg plus lamivudine 300 mg once daily
Continue current ART regimen
ACTIVE COMPARATORContinue current DHHS recommended or alternative three-drug antiretroviral regimen
Interventions
50 mg tablet by mouth once daily for 48 weeks
300 mg tablet by mouth once daily for 48 weeks
Continue current DHHS recommended or alternative three-drug antiretroviral regimen
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Babafemi Taiwolead
- ViiV Healthcarecollaborator
Study Sites (7)
University of California San Diego
San Diego, California, United States
Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, 60611, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Cornell University
New York, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Related Publications (1)
Taiwo BO, Marconi VC, Berzins B, Moser CB, Nyaku AN, Fichtenbaum CJ, Benson CA, Wilkin T, Koletar SL, Colasanti J, Acosta EP, Li JZ, Sax PE. Dolutegravir Plus Lamivudine Maintains Human Immunodeficiency Virus-1 Suppression Through Week 48 in a Pilot Randomized Trial. Clin Infect Dis. 2018 May 17;66(11):1794-1797. doi: 10.1093/cid/cix1131.
PMID: 29293895DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Babafemi Taiwo
- Organization
- Northwestern University
Study Officials
- PRINCIPAL INVESTIGATOR
Babafemi Taiwo, MBBS
Northwestern University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 6, 2014
First Posted
October 13, 2014
Study Start
December 1, 2014
Primary Completion
July 1, 2017
Study Completion
September 1, 2017
Last Updated
October 14, 2019
Results First Posted
November 13, 2018
Record last verified: 2019-10