A Phase IIIb Study of the Safety, Efficacy, and Tolerability of Switching to a Fixed-dose Combination of Abacavir/Dolutegravir/ Lamivudine From Current Antiretroviral Regimen
Public ClinicalTrials.gov record NCT02105987. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
201147: a Phase IIIb, Randomized, Open-label Study of the Safety, Efficacy, and Tolerability of Switching to a Fixed-dose Combination of Abacavir/Dolutegravir/ Lamivudine From Current Antiretroviral Regimen Compared With Continuation of the Current Antiretroviral Regimen in HIV-1 Infected Adults Who Are Virologically Suppressed, The STRIIVING Study.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is a 48-week, Phase IIIb, randomly assigned, open-label, active-controlled, multicenter, parallel group, non-inferiority study. This study is designed to demonstrate the non-inferior antiviral activity of switching to the Abacavir (ABC) 600 milligrams (mg)/Dolutegravir(DTG) 50 mg/Lamivudine (3TC) 300 mg fixed-dose combination (FDC) compared with continuing the subject's current suppressive regimen through 24 weeks. The study will be conducted in approximately 538 Human Immunodeficiency Virus -1 (HIV-1) infected individuals who are on stable suppressive combination antiretroviral therapy (cART) with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) plus either a protease inhibitor (PI), an non-nucleoside reverse transcriptase inhibitor (NNRTI), or an integrase inhibitor (INI). Eligible subjects will be randomly assigned 1:1 to continue their current regimen (approximately 269 subjects) or be switched to ABC/DTG/3TC FDC (approximately 269 subjects) once daily for 24 weeks. At Week 24, individuals originally randomly assigned to continue their current regimen will switch to ABC/DTG/3TC FDC and be followed for an additional 24 weeks. Individuals initially randomly assigned to ABC/DTG/3TC FDC will continue on that treatment arm for an additional 24 weeks. A pharmacokinetic (PK) substudy will be conducted at a small number of sites (approximately 10) to evaluate predose DTG concentrations as well as residual drug concentrations of efavirenz (EFV), nevaripine (NVP), amprenavir (APV) and tipranavir (TPV) in a subgroup of subjects who switch from EFV, NVP, fosamprenavir/ritonavir (FPV/r) or tipranavir/ritonavir (TPV/r).
Study identification
- NCT ID
- NCT02105987
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 555 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 2014 (Type not available)
- Primary completion
- Apr 2015 (Actual)
- Completion
- Dec 2015 (Actual)
- Last update posted
- Jan 4, 2017
2014 – 2015
United States locations
- U.S. sites
- 87
- U.S. states
- 28
- U.S. cities
- 67
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Phoenix | Arizona | 85012 | — |
| GSK Investigational Site | Phoenix | Arizona | 85015 | — |
| GSK Investigational Site | Bakersfield | California | 93301 | — |
| GSK Investigational Site | Beverly Hills | California | 90211 | — |
| GSK Investigational Site | Long Beach | California | 90813 | — |
| GSK Investigational Site | Los Angeles | California | 90028 | — |
| GSK Investigational Site | Los Angeles | California | 90033 | — |
| GSK Investigational Site | Los Angeles | California | 90035 | — |
| GSK Investigational Site | Los Angeles | California | 90036 | — |
| GSK Investigational Site | Los Angeles | California | 90069 | — |
| GSK Investigational Site | Newport Beach | California | 92663 | — |
| GSK Investigational Site | Oakland | California | 94602 | — |
| GSK Investigational Site | Sacramento | California | 95825 | — |
| GSK Investigational Site | San Diego | California | 92103 | — |
| GSK Investigational Site | San Francisco | California | 94109 | — |
| GSK Investigational Site | San Francisco | California | 94115 | — |
| GSK Investigational Site | San Francisco | California | 94118 | — |
| GSK Investigational Site | San Leandro | California | 94577 | — |
| GSK Investigational Site | Torrance | California | 90502 | — |
| GSK Investigational Site | Denver | Colorado | 80205-5422 | — |
| GSK Investigational Site | Denver | Colorado | 80209 | — |
| GSK Investigational Site | Norwalk | Connecticut | 06850 | — |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20007 | — |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20009 | — |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20036 | — |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20037 | — |
| GSK Investigational Site | Fort Lauderdale | Florida | 33316 | — |
| GSK Investigational Site | Ft. Pierce | Florida | 34982 | — |
| GSK Investigational Site | Jacksonville | Florida | 32209 | — |
| GSK Investigational Site | Miami | Florida | 33133 | — |
| GSK Investigational Site | Miami | Florida | 33136 | — |
| GSK Investigational Site | Orlando | Florida | 32803 | — |
| GSK Investigational Site | Pensacola | Florida | 32504 | — |
| GSK Investigational Site | Tampa | Florida | 33614 | — |
| GSK Investigational Site | Vero Beach | Florida | 32960-6571 | — |
| GSK Investigational Site | West Palm Beach | Florida | 33401 | — |
| GSK Investigational Site | Atlanta | Georgia | 30308 | — |
| GSK Investigational Site | Atlanta | Georgia | 30312 | — |
| GSK Investigational Site | Atlanta | Georgia | 30339 | — |
| GSK Investigational Site | Augusta | Georgia | 30912-3130 | — |
| GSK Investigational Site | Decatur | Georgia | 30033 | — |
| GSK Investigational Site | Savannah | Georgia | 31405 | — |
| GSK Investigational Site | Honolulu | Hawaii | 96813 | — |
| GSK Investigational Site | Chicago | Illinois | 60612-3833 | — |
| GSK Investigational Site | Chicago | Illinois | 60612 | — |
| GSK Investigational Site | Indianapolis | Indiana | 46202 | — |
| GSK Investigational Site | Iowa City | Iowa | 52242 | — |
| GSK Investigational Site | New Orleans | Louisiana | 70121 | — |
| GSK Investigational Site | Springfield | Massachusetts | 01105 | — |
| GSK Investigational Site | Ann Arbor | Michigan | 48109 | — |
| GSK Investigational Site | Berkley | Michigan | 48072 | — |
| GSK Investigational Site | Minneapolis | Minnesota | 55407 | — |
| GSK Investigational Site | Minneapolis | Minnesota | 55415 | — |
| GSK Investigational Site | Kansas City | Missouri | 64111 | — |
| GSK Investigational Site | St Louis | Missouri | 63108 | — |
| GSK Investigational Site | St Louis | Missouri | 63110 | — |
| GSK Investigational Site | St Louis | Missouri | 63139 | — |
| GSK Investigational Site | Las Vegas | Nevada | 89031 | — |
| GSK Investigational Site | Camden | New Jersey | 08103 | — |
| GSK Investigational Site | Hillsborough | New Jersey | 08844 | — |
| GSK Investigational Site | Newark | New Jersey | 07102 | — |
| GSK Investigational Site | Santa Fe | New Mexico | 87505 | — |
| GSK Investigational Site | Buffalo | New York | 14215 | — |
| GSK Investigational Site | Manhasset | New York | 11030 | — |
| GSK Investigational Site | New York | New York | 10001 | — |
| GSK Investigational Site | The Bronx | New York | 10467 | — |
| GSK Investigational Site | Valhalla | New York | 10595 | — |
| GSK Investigational Site | Charlotte | North Carolina | 28207 | — |
| GSK Investigational Site | Greensboro | North Carolina | 27401 | — |
| GSK Investigational Site | Akron | Ohio | 44304 | — |
| GSK Investigational Site | Cincinnati | Ohio | 45267-0405 | — |
| GSK Investigational Site | Tulsa | Oklahoma | 74127 | — |
| GSK Investigational Site | Allentown | Pennsylvania | 18102 | — |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19107 | — |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15212 | — |
| GSK Investigational Site | Charleston | South Carolina | 29425 | — |
| GSK Investigational Site | Austin | Texas | 78705 | — |
| GSK Investigational Site | Bellaire | Texas | 77401 | — |
| GSK Investigational Site | Dallas | Texas | 75208 | — |
| GSK Investigational Site | Dallas | Texas | 75246 | — |
| GSK Investigational Site | Dallas | Texas | 75390-9113 | — |
| GSK Investigational Site | Fort Worth | Texas | 76104 | — |
| GSK Investigational Site | Houston | Texas | 77098 | — |
| GSK Investigational Site | Longview | Texas | 75605 | — |
| GSK Investigational Site | Annandale | Virginia | 22003 | — |
| GSK Investigational Site | Lynchburg | Virginia | 24501 | — |
| GSK Investigational Site | Seattle | Washington | 98104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 16 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02105987, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 4, 2017 · Synced Oct 17, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02105987 live on ClinicalTrials.gov.