| 1 |
NCT01721109 |
Completed
Has Results |
Pharmacokinetics, Safety, and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen (STR) in Adolescents |
- Acquired Immunodeficiency Syndrome
- HIV Infections
|
|
Interventional
|
Phase 2
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- For Part A, Pharmacokinetic (PK) Parameter: AUCtau of EVG
- For Part B, Incidence of Treatment-Emergent Serious Adverse Events (SAEs) and All Treatment-Emergent Adverse Events (AEs)
- For Part A, PK Parameter: Ctau of EVG, FTC, Tenofovir (TFV), and COBI
- (and 7 more...)
|
50 |
All |
12 Years to 17 Years (Child) |
NCT01721109 |
GS-US-236-0112
2015-000313-40 |
|
December 6, 2012 |
October 22, 2015 |
January 29, 2018 |
November 5, 2012 |
March 9, 2018 |
April 10, 2017 |
- East Bay AIDS Center Medical Group
Oakland, California, United States - University of South Florida - Department of Pediatrics
Tampa, Florida, United States - University of Chicago
Chicago, Illinois, United States - (and 15 more...)
|
|
| 2 |
NCT01495702 |
Completed
Has Results |
Study to Evaluate Switching From Regimens Consisting of a Nonnucleoside Reverse Transcriptase Inhibitor Plus Emtricitabine and Tenofovir DF to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients |
- Acquired Immunodeficiency Syndrome
- HIV Infections
|
- Drug: NNRTI
- Drug: FTC/TDF
- Drug: Stribild
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96
- Change From Baseline in CD4+ Cell Count at Week 48
- Change From Baseline in CD4+ Cell Count at Week 96
|
439 |
All |
18 Years and older (Adult, Older Adult) |
NCT01495702 |
GS-US-236-0121
2011-004963-56 |
|
December 2011 |
November 2013 |
December 2014 |
December 20, 2011 |
January 7, 2016 |
January 26, 2015 |
- Spectrum Medical Group
Phoenix, Arizona, United States - AHF Research Center
Beverly Hills, California, United States - Pacific Oak Medical Group
Beverly Hills, California, United States - (and 77 more...)
|
|
| 3 |
NCT01533259 |
Completed
Has Results |
Open-Label Pilot Study to Evaluate Switching From a Regimen Consisting of Raltegravir Plus Emtricitabine/Tenofovir DF Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients |
- Acquired Immunodeficiency Syndrome
- HIV Infections
|
|
Interventional
|
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12
- Percentage of Participants With Adverse Events (AEs) and Graded Laboratory Abnormalities
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 24 and 48
|
48 |
All |
18 Years and older (Adult, Older Adult) |
NCT01533259 |
GS-US-236-0123 |
|
January 2012 |
November 2012 |
July 2013 |
February 15, 2012 |
January 26, 2015 |
January 26, 2015 |
- Kaiser Permanente Los Angeles
Los Angeles, California, United States - Peter J. Ruane, MD, Inc.
Los Angeles, California, United States - Anthony Mills MD, Inc
Los Angeles, California, United States - (and 6 more...)
|
|
| 4 |
NCT01475838 |
Completed
Has Results |
Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor Plus Emtricitabine/Tenofovir Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients |
- Acquired Immunodeficiency Syndrome
- HIV Infections
|
- Drug: PI
- Drug: RTV
- Drug: FTC/TDF
- Drug: Stribild
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96
- Change From Baseline in CD4+ Cell Count at Week 48
- Change From Baseline in CD4+ Cell Count at Week 96
|
438 |
All |
18 Years and older (Adult, Older Adult) |
NCT01475838 |
GS-US-236-0115
2011-004483-30 |
|
November 2011 |
November 2013 |
December 2014 |
November 21, 2011 |
June 8, 2016 |
January 26, 2015 |
- Spectrum Medical Group
Phoenix, Arizona, United States - Pueblo Family Physicians
Phoenix, Arizona, United States - AIDS Healthcare Foundation
Beverly Hills, California, United States - (and 96 more...)
|
|
| 5 |
NCT01797445 |
Active, not recruiting
Has Results |
Study to Evaluate the Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Positive, Antiretroviral Treatment-Naive Adults |
|
- Drug: E/C/F/TAF
- Drug: E/C/F/TDF
- Drug: E/C/F/TDF Placebo
- Drug: E/C/F/TAF Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 48
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96
- Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48 and 96
- (and 14 more...)
|
872 |
All |
18 Years and older (Adult, Older Adult) |
NCT01797445 |
GS-US-292-0111
2013-000102-37 |
|
March 12, 2013 |
September 17, 2014 |
June 2018 |
February 22, 2013 |
March 22, 2018 |
January 8, 2016 |
- University of Alabama at Birmingham
Birmingham, Alabama, United States - Spectrum Medical Group
Phoenix, Arizona, United States - Kaiser Permanente - Los Angeles Medical Center
Los Angeles, California, United States - (and 114 more...)
|
|
| 6 |
NCT01780506 |
Completed
Has Results |
Study to Evaluate the Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Positive, Antiretroviral Treatment-Naive Adults |
|
- Drug: E/C/F/TAF
- Drug: E/C/F/TDF
- Drug: E/C/F/TDF Placebo
- Drug: E/C/F/TAF Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96
- Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48 and 96
- (and 14 more...)
|
872 |
All |
18 Years and older (Adult, Older Adult) |
NCT01780506 |
GS-US-292-0104
2012-004458-27 |
|
December 26, 2012 |
August 26, 2014 |
September 6, 2017 |
January 31, 2013 |
November 6, 2017 |
January 8, 2016 |
- The University of Alabama at Birmingham
Birmingham, Alabama, United States - Spectrum Medical Group
Phoenix, Arizona, United States - Kaiser Permanente Los Angeles
Los Angeles, California, United States - (and 114 more...)
|
|
| 7 |
NCT01497899 |
Completed
Has Results |
Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Infected, Antiretroviral Treatment-Naive Adults |
- Acquired Immunodeficiency Syndrome
- HIV Infections
|
- Drug: E/C/F/TDF
- Drug: E/C/F/TAF Placebo
- Drug: E/C/F/TAF
- Drug: E/C/F/TDF Placebo
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
- Change From Baseline in log10 HIV-1 RNA at Weeks 24 and 48
- Change From Baseline in CD4+ Cell Count at Weeks 24 and 48
|
279 |
All |
18 Years and older (Adult, Older Adult) |
NCT01497899 |
GS-US-292-0102 |
|
December 28, 2011 |
October 17, 2012 |
August 22, 2016 |
December 23, 2011 |
September 20, 2017 |
January 8, 2016 |
- University of Alabama at Birmingham (UAB)
Birmingham, Alabama, United States - Spectrum Medical Group
Phoenix, Arizona, United States - AHF Research Center
Beverly Hills, California, United States - (and 38 more...)
|
|
| 8 |
NCT01705574 |
Active, not recruiting
Has Results |
Safety and Efficacy of E/C/F/TDF (Stribild®) Versus RTV-Boosted ATV Plus FTC/TDF (Truvada®) in HIV-1 Infected, Antiretroviral Treatment-Naive Women |
- Acquired Immunodeficiency Syndrome
- HIV Infections
|
- Drug: E/C/F/TDF
- Drug: RTV
- Drug: ATV
- (and 6 more...)
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 of the Double-Blind Phase
- Change From Baseline in CD4+ Cell Count at Week 48 of the Double-Blind Phase
- Percentage of Participants Receiving Open-Label E/C/F/TDF With HIV-1 RNA < 50 Copies/mL at Week 48 of the Open- Label Extension Phase
- (and 2 more...)
|
583 |
Female |
18 Years and older (Adult, Older Adult) |
NCT01705574 |
GS-US-236-0128
2012-003708-11 |
WAVES |
October 24, 2012 |
February 11, 2015 |
September 2018 |
October 12, 2012 |
March 15, 2018 |
March 10, 2016 |
- University of Southern California AIDS Clinical Trials Group
Los Angeles, California, United States - University of California, Davis Medical Center
Sacramento, California, United States - Whitman-Walker Health
Washington, District of Columbia, United States - (and 96 more...)
|
|
| 9 |
NCT02251236 |
Completed |
Elvitegravir (EVG) Cerebrospinal Fluid (CSF) Pharmacokinetics in HIV-Infected Individuals |
|
- Drug: Stribild
- Drug: Genvoya
|
Interventional
|
Not Applicable |
- University of California, San Diego
- Gilead Sciences
- University at Buffalo
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Determine the concentrations of elvitegravir, tenofovir and TAF in cerebrospinal fluid (CSF)
- Compare tenofovir concentrations in CSF with E/C/F/TDF to tenofovir concentrations in CSF with E/C/F/TAF.
- Compare changes in drug concentrations in CSF over 24 weeks to changes in drug concentrations in blood
- (and 3 more...)
|
14 |
All |
18 Years to 60 Years (Adult) |
NCT02251236 |
IN-US-236-1266 |
|
January 2016 |
January 18, 2017 |
January 18, 2017 |
September 29, 2014 |
May 24, 2017 |
|
- UC San Diego AntiViral Research Center
San Diego, California, United States
|
|
| 10 |
NCT02652624 |
Active, not recruiting |
Safety and Efficacy of Switching to a FDC of B/F/TAF From E/C/F/TAF, E/C/F/TDF, or ATV+RTV+FTC/TDF in Virologically Suppressed HIV-1 Infected Women |
|
- Drug: E/C/F/TAF
- Drug: E/C/F/TDF
- Drug: ATV
- (and 3 more...)
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Proportion of Participants With HIV-1 RNA ≥ 50 copies/mL at Week 48 as Determined by the US FDA-Defined Snapshot Algorithm
- Proportion of Participants With HIV-1 RNA < 50 copies/mL at Week 48 as Determined by the US FDA-Defined Snapshot Algorithm
- Change From Baseline in CD4+ Cell Count at Week 48
|
471 |
Female |
18 Years and older (Adult, Older Adult) |
NCT02652624 |
GS-US-380-1961 |
|
February 1, 2016 |
October 9, 2017 |
October 2018 |
January 12, 2016 |
February 27, 2018 |
|
- Stamford, Connecticut, United States
- Washington, District of Columbia, United States
- Washington, District of Columbia, United States
- (and 53 more...)
|
|
| 11 |
NCT01855867 |
Completed |
HIV Non-Occupational Post-Exposure Prophylaxis |
- Human Immunodeficiency Virus
|
- Drug: Coformulated Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg)
|
Interventional
|
Phase 4 |
- Kenneth H. Mayer, MD
- Gilead Sciences
- Fenway Community Health
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Safety and Tolerability - as measured by number of participants with adverse events, the severity of adverse events and frequency of adverse events
- Awareness and attitudes around non-occupational post-prophylaxis
- Awareness and attitudes around HIV pre-exposure prophylaxis
- Adherence compared to other nPEP regimens studied at Fenway Health or from literature review.
|
100 |
All |
18 Years and older (Adult, Older Adult) |
NCT01855867 |
QUAD
IND: 116,967 |
QUAD |
May 2013 |
April 2014 |
April 2016 |
May 17, 2013 |
January 26, 2017 |
|
- Fenway Community Health
Boston, Massachusetts, United States
|
|
| 12 |
NCT02283060 |
Unknown † |
Sleep and Cognition After Atripla to Stribild Switch |
|
- Drug: Stribild
- Drug: Atripla
|
Interventional
|
Phase 4 |
- University of Hawaii
- Gilead Sciences
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- Change in sleep architecture assessed by formal sleep study
- Change in neuropsychological performance global and subdomain neuropsychological test scores
- Change in Pittsburgh Sleep Quality Index Score
- (and 2 more...)
|
30 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT02283060 |
H027 |
|
September 2014 |
July 2016 |
August 2016 |
November 5, 2014 |
March 14, 2016 |
|
- Hawaii Center for AIDS
Honolulu, Hawaii, United States
|
|
| 13 |
NCT02616783 |
Completed |
Switching From a Tenofovir Disoproxil Fumarate (TDF) Containing Regimen to Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Alafenamide (E/C/F/TAF) Fixed-Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Infected Adults Aged ≥ 60 Years |
|
- Drug: E/C/F/TAF
- Drug: TDF
- Drug: FTC
- (and 3 more...)
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percent change from baseline to Week 48 in spine and hip bone mineral density (BMD)
- Percent change from baseline to Week 24 in spine and hip BMD
- Proportion of participants with HIV-1 RNA < 50 copies/mL at Weeks 24 and 48 as defined by the Food and Drug Administration (FDA) snapshot algorithm
- Change in CD4+ cell count from baseline at Weeks 24 and 48
|
166 |
All |
60 Years and older (Adult, Older Adult) |
NCT02616783 |
GS-US-292-1826
2015-002712-32 |
pts > 60 yrs |
December 22, 2015 |
February 21, 2018 |
March 21, 2018 |
November 30, 2015 |
April 3, 2018 |
|
- CHU Saint-Pierre University Hospital
Brussels, Belgium - University Hospital Gent
Ghent, Belgium - CHU - Groupe Saint-Andre
Bordeaux, France - (and 32 more...)
|
|
| 14 |
NCT03425994 |
Not yet recruiting |
Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide as Maintenance Treatment for HIV/HBV-coinfection |
- Chronic Hepatitis B in HIV Patient
- Kidney Injury
- Bone Diseases
|
- Drug: Elvitegravir/Cobicistat/Emtricitabine
|
Observational
|
|
- National Taiwan University Hospital
- National Taiwan University Hospital Hsin-Chu Branch
- National Taiwan University Hospital, Yun-Lin Branch
- (and 13 more...)
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Proportion of patients with undetectable plasma HBV DNA load
- Decreases of plasma HBV DNA load
- Proportion of patients with plasma HIV RNA load <50 copies/mL
- (and 11 more...)
|
200 |
All |
20 Years and older (Adult, Older Adult) |
NCT03425994 |
201710056RIPB |
|
April 2018 |
October 2019 |
January 2020 |
February 8, 2018 |
February 8, 2018 |
|
|
|
| 15 |
NCT02180438 |
Completed
Has Results |
An Open Label Trial of Stribild for Antiretroviral (ARV)-naïve HIV-2 Infected Adults in Dakar, Senegal |
|
- Drug: Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
|
Interventional
|
Phase 4 |
- University of Washington
- Clinique des Maladies Infectieuses Ibrahima DIOP Mar/CRCF, Centre Hospitalier Universitaire de Fann
- Gilead Sciences
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Death
- New WHO Stage 3 or 4 Event
- Virologic Failure, FDA Snapshot (HIV-2 Plasma Viral Load >50 and >400 Copies/ml)
- (and 5 more...)
|
30 |
All |
18 Years and older (Adult, Older Adult) |
NCT02180438 |
STUDY00000757 |
Stribild HIV-2 |
September 2014 |
January 2017 |
January 2017 |
July 2, 2014 |
May 8, 2018 |
May 8, 2018 |
- Clinique des Maladies Infectieuses Ibrahima DIOP Mar/CRCF, Centre Hospitalier Universitaire de Fann
Dakar, Senegal
|
|
| 16 |
NCT02246998 |
Completed
Has Results |
Renal Effect of Stribild or Other Tenofovir DF-containing Regimens Compared to Ritonavir-boosted Atazanavir Plus Abacavir/Lamivudine in Antiretroviral Treatment-naive HIV-1 Infected Adults |
|
- Drug: STB
- Drug: TVD
- Drug: ATR
- (and 4 more...)
|
Interventional
|
Phase 4 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Actual Glomerular Filtration Rate (aGFR) Using Iohexol Plasma Clearance (CLiohexol) at Week 24
- Estimated GFR (eGFR) Calculated by Cockcroft-Gault Formula at Week 24
- Estimated GFR Calculated by Modification of Diet in Renal Disease (MDRD) Formula at Week 24
- (and 35 more...)
|
72 |
All |
18 Years to 55 Years (Adult) |
NCT02246998 |
GS-US-236-0140
2014-002095-93 |
|
December 15, 2014 |
January 20, 2016 |
February 17, 2016 |
September 23, 2014 |
January 3, 2018 |
January 3, 2018 |
- Brussels, Belgium
- Ghent, Belgium
- Lyon, France
- (and 17 more...)
|
|
| 17 |
NCT02198443 |
Completed |
Comparison of Two Combinations in Antiretroviral Post-Exposure Prophylaxis for HIV-1: Tenofovir/Emtricitabine (Truvada ®) + Lopinavir/Ritonavir (Kaletra ®) vs Tenofovir/Emtricitabine/Cobicistat/Elvitegravir (Stribild ®). Prospective, Randomized, Open. |
|
- Drug: Tenofovir + emtricitabine (Truvada),+lopinavir/ritonavir (Kaletra)
- Drug: elvitegravir/cobicistat/emtricitabine/Tenofovir-Disoproxil
|
Interventional
|
Phase 4 |
- Fundacion Clinic per a la Recerca Biomédica
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Proportion of patients who leave the initial treatment of post-exposure prophylaxis (PEP) for HIV for any reason
- Incidence of clinical adverse events and / or laboratory alterations.
- Proportion of patients who discontinued treatment due to toxicity or intolerance in each of the treatment arms at 24 weeks follow-up
- (and 3 more...)
|
160 |
All |
18 Years and older (Adult, Older Adult) |
NCT02198443 |
STRIB-PEP |
STRIB-PEP |
June 6, 2015 |
July 15, 2016 |
|
July 23, 2014 |
February 23, 2017 |
|
- Hospital clínico y provincial de Barcelona
Barcelona, Spain
|
|
| 18 |
NCT00869557 |
Completed
Has Results |
Study of the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults |
|
- Drug: Stribild
- Drug: Atripla
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- The Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) Less Than 50 Copies/mL at Week 24
- The Percentage of Participants With HIV-1 RNA Less Than 50 Copies/mL at Week 48
- Change From Baseline in HIV-1 RNA (log_10 Copies/mL)
- (and 3 more...)
|
71 |
All |
18 Years and older (Adult, Older Adult) |
NCT00869557 |
GS-US-236-0104 |
|
April 2009 |
November 2009 |
September 2013 |
March 26, 2009 |
June 4, 2014 |
October 22, 2012 |
- Health for Life Clinic, PLLC
Little Rock, Arkansas, United States - The Living Hope Foundation
Long Beach, California, United States - Peter J. Ruane, MD, Inc.
Los Angeles, California, United States - (and 27 more...)
|
|
| 19 |
NCT01095796 |
Completed
Has Results |
Study to Evaluate the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults |
|
- Drug: Stribild
- Drug: Atripla
- Drug: Stribild Placebo
- Drug: Atripla Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- The Percentage of Participants With Virologic Success Using the Food and Drug Administration (FDA)-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 Ribonucleic Acid (RNA) < 50 Copies/mL at Week 48
- The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 96
- The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 144
- (and 4 more...)
|
707 |
All |
18 Years and older (Adult, Older Adult) |
NCT01095796 |
GS-US-236-0102 |
|
March 2010 |
August 2011 |
September 2014 |
March 30, 2010 |
November 11, 2015 |
October 22, 2012 |
- University of Alabama at Birmingham
Birmingham, Alabama, United States - Spectrum Medical Group
Phoenix, Arizona, United States - Health for Life Clinic PLLC
Little Rock, Arkansas, United States - (and 99 more...)
|
|
| 20 |
NCT02199613 |
Completed |
Elvitegravir/Cobicistat/Tenofovir DF/Emtricitabine With Darunavir Treatment Simplification Strategy |
|
- Drug: Treatment simplification
|
Interventional
|
Phase 4 |
- University of British Columbia
- Gilead Sciences
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Plasma HIV RNA
- plasma HIV RNA
- CD4 cell count, CD4% and CD4/CD8 ratio
- (and 8 more...)
|
10 |
All |
19 Years and older (Adult, Older Adult) |
NCT02199613 |
H14-00490 |
QuaDar |
October 2014 |
February 14, 2017 |
February 14, 2017 |
July 24, 2014 |
November 6, 2017 |
|
- St. Paul's Hospital Immunodeficiency Clinic
Vancouver, British Columbia, Canada
|
|
| 21 |
NCT02616029 |
Recruiting |
Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) in Virologically-Suppressed HIV-1 Infected Adults Harboring the Archived Isolated NRTI Resistance Mutation M184V/M184I |
|
|
Interventional
|
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Proportion of participants with HIV-1 RNA < 50 copies/mL at Week 12 as defined by pure virologic response (PVR)
- Proportion of participants with emergence of new mutations in HIV-1 reverse transcriptase and integrase
- Proportion of participants with HIV-1 RNA < 50 copies/mL at Weeks 24 and 48 using PVR
- (and 2 more...)
|
100 |
All |
18 Years and older (Adult, Older Adult) |
NCT02616029 |
GS-US-292-1824
2015-002710-74 |
|
December 17, 2015 |
January 2019 |
September 2019 |
November 26, 2015 |
June 6, 2018 |
|
- Southern California Men's Medical Group
Los Angeles, California, United States - Gary Richmond, MD, PA, Inc.
Fort Lauderdale, Florida, United States - Midway Immunology & Research Center, LLC
Fort Pierce, Florida, United States - (and 33 more...)
|
|
| 22 |
NCT01929759 |
Completed
Has Results |
Advanced Neuroimaging Evaluation of the Central Nervous System Biological Changes Associated With Efavirenz Therapy and Switch to an Elvitegravir-based Regimen |
|
- Drug: Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir)
|
Interventional
|
Not Applicable |
- Massachusetts General Hospital
- Brigham and Women's Hospital
- Gilead Sciences
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Change in Neurometabolites Based on Magnetic Resonance Spectroscopy (MRS)
- Neural Activation Networks Using Functional Magnetic Resonance Imaging (fMRI)
- Change in Other Neurometabolite Measured by MRS Between Week 0 and Week 8
- (and 6 more...)
|
10 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT01929759 |
NeuroHIV001 |
|
January 2014 |
October 2015 |
October 2015 |
August 28, 2013 |
July 28, 2017 |
July 28, 2017 |
- Brigham and Women's Hospital
Boston, Massachusetts, United States
|
|
| 23 |
NCT01106586 |
Completed
Has Results |
Study to Evaluate the Safety and Efficacy of Stribild Versus Ritonavir-Boosted Atazanavir Plus Truvada in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults |
|
- Drug: Stribild
- Drug: ATV
- Drug: Ritonavir
- (and 5 more...)
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- The Percentage of Participants With Virologic Success Using the Food and Drug Administration (FDA)-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 Ribonucleic Acid (RNA) < 50 Copies/mL at Week 48
- The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 96
- The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 144
- (and 4 more...)
|
708 |
All |
18 Years and older (Adult, Older Adult) |
NCT01106586 |
GS-US-236-0103 |
|
April 2010 |
September 2011 |
September 2014 |
April 20, 2010 |
November 11, 2015 |
October 22, 2012 |
- Spectrum Medical Group
Phoenix, Arizona, United States - Health for Life Clinic PLLC
Little Rock, Arkansas, United States - AHF Research Center
Beverly Hills, California, United States - (and 143 more...)
|
|
| 24 |
NCT02306577 |
Unknown † |
STRIBILD in Non-Nucleoside Resistant Patients (SINNR STUDY) |
|
|
Observational
|
|
- Vancouver Infectious Diseases Centre
- Gilead Sciences
- Regina General Hospital
|
Other / Industry |
- Time Perspective: Prospective
|
- Virologic Efficacy (viral load <50copies/ml after taking STRIBILD)
- Safety-Side Effect Profile and Number of Participants with Adverse Events
- Immunologic Response-CD4 Cell Count and Change in CD4 Cell Count at 48 Weeks
- (and 2 more...)
|
30 |
All |
19 Years to 70 Years (Adult, Older Adult) |
NCT02306577 |
SINNR STUDY |
SINNR |
November 2014 |
April 2016 |
July 2016 |
December 3, 2014 |
June 3, 2015 |
|
- Vancouver ID Research and Care Centre Society
Vancouver, British Columbia, Canada
|
|
| 25 |
NCT03405935 |
Recruiting |
A Study to Evaluate Switching From an E/C/F/TAF FDC Regimen or a TDF Containing Regimen to B/F/TAF FDC in HIV-1 Infected Adults |
|
|
Interventional
|
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Proportion of Participants With HIV-1 RNA < 50 Copies / mL at Week 24 Defined by the Food and Drug Administration (FDA) Snapshot Algorithm
- Proportion of Participants Experiencing Adverse Events Through Week 24
- Proportion of Participants Experiencing Adverse Events Through Week 48
- Proportion of Participants With HIV-1 RNA < 50 copies / mL at Week 48 Defined by the FDA Snapshot Algorithm
|
80 |
All |
65 Years and older (Older Adult) |
NCT03405935 |
GS-US-380-4449
2017-003428-61 |
|
March 1, 2018 |
November 2018 |
May 2020 |
January 23, 2018 |
May 14, 2018 |
|
- CHU Saint-Pierre
Brussels, Belgium - UZ Gent
Ghent, Belgium - CHU Bordeaux - Groupe Hospitalier Sud
Bordeaux, France - (and 23 more...)
|
|
| 26 |
NCT02325934 |
Completed |
Bioequivalence of Crushed Stribild With a Normal Breakfast or With Drip Feed Compared to the Whole Tablet |
|
- Drug: Stribild
- Drug: Stribild, crushed
|
Interventional
|
Phase 1 |
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
|
|
24 |
All |
18 Years to 55 Years (Adult) |
NCT02325934 |
UMCN AKF 14.03 |
CRUSTRI |
February 2015 |
February 2015 |
February 2015 |
December 25, 2014 |
May 7, 2015 |
|
- CRCN, Radboud University Medical Center
Nijmegen, Netherlands
|
|
| 27 |
NCT01815580 |
Recruiting |
HIV Test and Treat to Prevent HIV Transmission Among MSM and Transgender Women |
|
- Drug: Atripla or Stribild
|
Interventional
|
Phase 4 |
- Fred Hutchinson Cancer Research Center
- Asociación Civil Impacta Salud y Educación, Peru
- NGO Via Libre
- Epicentro, Barranco District, Peru
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- HIV viral load
- Risk factors for acute/recent HIV infection
- Linkage to care
- Retention in care
|
150 |
Male |
18 Years and older (Adult, Older Adult) |
NCT01815580 |
TNT-Peru |
SABES? |
July 2013 |
June 2020 |
August 2020 |
March 21, 2013 |
September 1, 2017 |
|
- Asociación Civil Impacta Salud y Educación
Lima, Peru
|
|
| 28 |
NCT02351908 |
Completed |
Renal Integrase Study |
|
- Drug: Stribild® (Tenofovir Disoproxil Fumarate, Elvitegravir, Cobicistat)
- Drug: Isentress® (Raltegravir 400 mg)1 tablet twice a day + Truvada® (FTC & Tenofovir) 1 tablet
- Drug: Tivicay® (Dolutegravir 50 mg) 1 tablet once a day + Truvada® (FTC & Tenofovir)
|
Interventional
|
Phase 4 |
- St Stephens Aids Trust
- Merck Sharp & Dohme Corp.
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Health Services Research
|
- Change in retinol-binding protein/creatinine ratio (PCR) with each regimen over 24 weeks.
- Change in retinol-binding protein/creatinine ratio with each regimen over 12 and 48 weeks.
- eGFR
- (and 6 more...)
|
60 |
All |
18 Years to 64 Years (Adult) |
NCT02351908 |
SSAT 066 |
|
March 2015 |
April 2016 |
April 2017 |
January 30, 2015 |
June 27, 2017 |
|
- SSAT Clinical Research Facility
London, United Kingdom
|
|
| 29 |
NCT02660905 |
Active, not recruiting |
HIV Drug Switch Followed by HCV Therapy in HIV-HCV Co-Infection |
- Human Immunodeficiency Virus
- Hepatitis C, Chronic
|
- Drug: E/C/F/TAF;
- Drug: Ledipasvir-Sofosbuvir
|
Interventional
|
Phase 3 |
- Ottawa Hospital Research Institute
- Gilead Sciences
- CIHR Canadian HIV Trials Network
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Proportion of approached patients who agreed to switch from their current ARV regimen and be screened for this study
- Screen failures due to Drug-drug Interactions (DDI)
- Screen failures due to prior documented antiretroviral (ARV) resistance to Integrase Inhibitors and/or nucleoside reverse transcriptase inhibitors (NRTIs)
- (and 5 more...)
|
25 |
All |
18 Years and older (Adult, Older Adult) |
NCT02660905 |
20150881-01H |
CTN289 |
April 2016 |
November 2017 |
December 2017 |
January 21, 2016 |
April 26, 2017 |
|
- The Ottawa Hospital, General Campus
Ottawa, Ontario, Canada - The Research Institute of the McGill University Health Centre
Montreal, Quebec, Canada
|
|
| 30 |
NCT02220868 |
Completed |
Sofosbuvir, Ribavirin, for the Treatment of Chronic Hepatitis C Virus Genotype 1 in HIV-Coinfected Patients Receiving Fixed Dose Co-formulation Emtricitabine/ Tenofovir/Cobicistat/Elvitegravir: A Pilot Study |
- Hepatitis C Infection
- HIV Infection
|
- Drug: Sofosbuvir, Ribavirin, and Stribild
|
Interventional
|
Phase 4 |
- Saint Michael's Medical Center
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- • SVR,12 defined as undetectable HCV RNA levels for 12 weeks after the completion of therapy
|
10 |
All |
18 Years to 99 Years (Adult, Older Adult) |
NCT02220868 |
IN-US-334-1527 |
|
July 2014 |
August 2015 |
September 2015 |
August 20, 2014 |
August 4, 2016 |
|
- Saint Michael's Medical Center
Newark, New Jersey, United States
|
|
| 31 |
NCT01854775 |
Active, not recruiting |
Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children |
- Acquired Immune Deficiency Syndrome (AIDS)
- HIV Infections
|
|
Interventional
|
Phase 2
Phase 3 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Pharmacokinetic (PK) Parameter: AUCtau for EVG (Part A)
- PK Parameter: AUClast for TAF (Part A)
- Incidence of Treatment-Emergent Serious Adverse Events (Part B)
- (and 14 more...)
|
100 |
All |
6 Years to 17 Years (Child) |
NCT01854775 |
GS-US-292-0106
2013-002780-26 |
|
May 6, 2013 |
July 2018 |
December 2021 |
May 16, 2013 |
February 27, 2018 |
|
- Miller's Children Hospital
Long Beach, California, United States - Children's National Medical Center
Washington, District of Columbia, United States - Emory University School of Medicine
Atlanta, Georgia, United States - (and 7 more...)
|
|
| 32 |
NCT02477527 |
Completed
Has Results |
Atripla to Stribild Switch Study to Evaluate Sleep Disturbances |
|
|
Interventional
|
Phase 4 |
- Midtown Medical Center, Tampa, FL
- Gilead Sciences
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Patients With Viral Loads < 50 Following the Switch
- T-cell Changes
- Improvements in Central Nervous System Toxicity Score
- Improvements in Sleep Disorder Score
|
21 |
All |
18 Years and older (Adult, Older Adult) |
NCT02477527 |
EB001JP001 |
|
February 2015 |
December 2015 |
January 2016 |
June 22, 2015 |
July 28, 2017 |
July 2, 2017 |
|
|
| 33 |
NCT01967940 |
Completed
Has Results |
Efficacy of Tenofovir Alafenamide Versus Placebo Added to a Failing Regimen Followed by Treatment With Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Plus Atazanavir in HIV-1 Positive, Antiretroviral Treatment-Experienced Adults |
- HIV
- HIV Infections
- Acquired Immunodeficiency Syndrome
|
- Drug: TAF
- Drug: Placebo
- Drug: E/C/F/TAF
- (and 2 more...)
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Part 1: Percentage of Participants With Plasma HIV-1 RNA Decreases From Baseline Exceeding 0.5 log10 at Day 10
- Part 1: Change From Baseline in Plasma log10 HIV-1 RNA (Copies/mL) at Day 10
- Part 2: Safety of E/C/F/TAF STR Plus ATV in Participants Who Switched From a Failing Regimen as Assessed by the Incidence of Laboratory Parameters and Adverse Events at Weeks 24 and 48
- (and 9 more...)
|
55 |
All |
18 Years and older (Adult, Older Adult) |
NCT01967940 |
GS-US-292-0117
2013-002830-19 |
|
October 25, 2013 |
May 9, 2016 |
July 31, 2017 |
October 23, 2013 |
September 13, 2017 |
June 12, 2017 |
- Midway Immunology and Research center
Fort Pierce, Florida, United States - Triple O Research Institute, P.A.
West Palm Beach, Florida, United States - Rowan Tree Medical, P.A.
Wilton Manors, Florida, United States - (and 12 more...)
|
|
| 34 |
NCT01694420 |
Completed
Has Results |
Treatment of Acute HIV Infection With Quad Fixed-dose Combination (FDC) Tablet |
|
- Drug: (FDC) ELV/COBI/FTC/TDF
|
Interventional
|
Phase 3 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Participants With a Viral Load Measurement of <200 Copies/mL at Week 24
- Virologic Efficacy of the Fixed Dose Combination (FDC) ELV/COBI/FTC/TDF Given Once Daily to Participants With Acute HIV Infection as Determined by the Proportion of Treated Participants With HIV-1 RNA to <50 Copies/mL at Week 48
- Immune Activation as Measured by the Proportion of CD4+ and CD8+ Cells Expressing HLA-DR and CD38+
- Rate of Virologic Decline in the First 48 Weeks of Treatment Comparing FDC ELV/COBI/FTC/TDF to FDC EFV/FTC/TDF
|
33 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT01694420 |
Pro00035447
IN-US-236-0124 |
PHI04 |
September 2012 |
April 2016 |
February 2017 |
September 27, 2012 |
April 12, 2017 |
December 23, 2016 |
- UNC at Chapel Hill
Chapel Hill, North Carolina, United States - Duke University Medical Center
Durham, North Carolina, United States
|
|
| 35 |
NCT01968551 |
Completed
Has Results |
Phase 3 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) Plus Darunavir (DRV) in Treatment Experienced HIV-1 Positive Adults |
- HIV-1
- HIV Infections
- Acquired Immunodeficiency Syndrome
|
- Drug: E/C/F/TAF
- Drug: DRV
- Drug: Baseline DRV- containing ARV regimen
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participants in Each Treatment Arm in Cohort 2 With HIV-1 RNA < 50 Copies/mL at Week 24
- Percentage of Participants in Each Treatment Arm in Cohort 2 With HIV-1 RNA < 50 Copies/mL at Week 48
- Change From Baseline in CD4+ Cell Count at Week 24
- Change From Baseline in CD4+ Cell Count at Week 48
|
158 |
All |
18 Years and older (Adult, Older Adult) |
NCT01968551 |
GS-US-292-0119 |
|
September 3, 2013 |
July 21, 2015 |
July 9, 2016 |
October 24, 2013 |
August 14, 2017 |
November 1, 2016 |
- Pueblo Family Physicians, Ltd.
Phoenix, Arizona, United States - Pacific Oaks Medical Group
Beverly Hills, California, United States - Kaiser Permanente
Hayward, California, United States - (and 59 more...)
|
|
| 36 |
NCT02203461 |
Completed |
Changes in Insulin Resistance in Healthy Volunteers on STRIBILD® Medication |
|
- Drug: Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat
- Drug: Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavir
- Drug: Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavir
|
Interventional
|
Phase 1 |
- Technische Universität München
- Gilead Sciences
- MUC Research GmbH
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Changes in insulin resistance, measured by hyperinsulinemic euglycemic clamp
- Changes in metabolic parameters
|
30 |
Male |
18 Years to 40 Years (Adult) |
NCT02203461 |
STR-1383--0030-I
2014-000359-98 |
|
July 2014 |
October 2014 |
October 2014 |
July 30, 2014 |
November 5, 2014 |
|
- University Hospital Klinikum rechts der Isar (TUM)
Munich, Bavaria, Germany
|
|
| 37 |
NCT01363011 |
Completed
Has Results |
Cobicistat-containing Highly Active Antiretroviral Regimens in HIV-1 Infected Patients With Mild to Moderate Renal Impairment |
- Acquired Immunodeficiency Syndrome
- HIV Infections
|
- Drug: E/C/F/TDF
- Drug: COBI
- Drug: ATV
- (and 2 more...)
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using the Cockcroft-Gault (CG) Equation at Week 24 (Cohort 1)
- Change From Baseline in eGFR-CG at Week 24 (Cohort 2)
- Change From Baseline in eGFR Using the Modification of Diet in Renal (MDRD) Equation at Week 24 (Cohort 1)
- (and 33 more...)
|
106 |
All |
18 Years and older (Adult, Older Adult) |
NCT01363011 |
GS-US-236-0118 |
|
May 2011 |
January 2013 |
February 2015 |
June 1, 2011 |
May 2, 2016 |
October 31, 2014 |
- Spectrum Medical Group
Phoenix, Arizona, United States - Health for Life Clinic
Little Rock, Arkansas, United States - AHF Research Center
Beverly Hills, California, United States - (and 48 more...)
|
|
| 38 |
NCT03549312 |
Recruiting
New |
Switch to Genvoya Followed by HCV Therapy With Epclusa in Patients With HIV/HCV Co-Infection on Methadone |
- HIV-1-infection
- Hepatitis C, Chronic
- Intravenous Drug Usage
- (and 6 more...)
|
- Drug: Genvoya
- Drug: Epclusa
|
Interventional
|
Phase 4 |
- Saskatchewan Health Authority - Regina Area
- Gilead Sciences
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Feasibility assessment: participants approached, screened and enrolled in the study along with completed study visits
- Adherence
- HIV treatment outcome
- (and 11 more...)
|
25 |
All |
18 Years and older (Adult, Older Adult) |
NCT03549312 |
REB-17-22 |
|
February 1, 2018 |
June 30, 2019 |
June 30, 2019 |
June 8, 2018 |
June 8, 2018 |
|
- Saskatchewan Health Authority
Regina, Saskatchewan, Canada
|
|
| 39 |
NCT03251144 |
Recruiting |
Relative Mitochondrial Toxicity of Tenofovir Alafenamide (TAF) vs. Tenofovir Disoproxil Fumarate (TDF) |
- HIV/AIDS
- Antiviral Toxicity
- Antiviral Drug Adverse Reaction
- Mitochondrial Alteration
|
- Drug: Switch to E/C/FTC/TAF daily
|
Interventional
|
Phase 1
Phase 2 |
- University of California, Los Angeles
- Gilead Sciences
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Change in mitochondrial function [cellular oxygen consumption (COC)] over 12 months after switch of antiretrovirals.
- Change in mitochondrial function [membrane potential (Δψm)] over 12 months after switch of antiretrovirals.
- Change in mitochondrial function [mitochondrial reactive oxygen species (mito-ROS)] over 12 months after switch of antiretrovirals.
- (and 2 more...)
|
35 |
All |
18 Years to 80 Years (Adult, Older Adult) |
NCT03251144 |
CO-US-311-4393 |
UCLACAREMITO |
September 8, 2018 |
January 8, 2020 |
July 31, 2020 |
August 16, 2017 |
May 22, 2018 |
|
- UCLA CARE Center
Los Angeles, California, United States
|
|
| 40 |
NCT02707601 |
Completed |
Efficacy, Safety, and Tolerability of Ledipasvir/Sofosbuvir (LDV/SOF) Treatment for HIV/HCV Co-infected Participants Who Switch to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) or Emtricitabine/Rilpivirine/Tenofovir Alafenamide (F/R/TAF) Prior to LDV/SOF HCV Treatment |
- HIV-1 Infection
- HCV Infection
|
- Drug: E/C/F/TAF
- Drug: F/R/TAF
- Drug: LDV/SOF
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Proportion of Participants with Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of LDV/SOF Treatment (SVR12)
- Proportion of Participants with HCV RNA < LLOQ at 4 Weeks After Discontinuation of LDV/SOF Treatment (SVR4)
- The Proportion of Participants with HIV-1 RNA ≥ 50 copies/mL (Virologic Failure) 24 Weeks After Start of the F/TAF-Based Regimen Using Modified FDA Snapshot Algorithm
- Incidence of Adverse Events
|
150 |
All |
18 Years and older (Adult, Older Adult) |
NCT02707601 |
GS-US-366-1992
2014-004545-27 |
Co-STARs |
April 1, 2016 |
September 14, 2017 |
September 29, 2017 |
March 14, 2016 |
October 5, 2017 |
|
- University of Alabama at Birmingham
Birmingham, Alabama, United States - Spectrum Medical Group
Phoenix, Arizona, United States - Mills Clinical Research
Los Angeles, California, United States - (and 39 more...)
|
|
| 41 |
NCT03067285 |
Recruiting |
A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study |
|
- Drug: ELV/COBI/FTC/TAF
- Drug: DTG/3TC/ABC + ELV/COBI/FTC/TAF
|
Interventional
|
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To compare changes in the severity of neuropsychiatric symptoms potentially associated with the use of DTG/3TC/ABC, perceived by patients randomised to begin isolated symptomatic treatment or treatment associated with switching antiretroviral therapy.
- To evaluate changes in the severity of neuropsychiatric symptoms potentially associated with the use of DTG/3TC/ABC after switching to ELV/COBI/FTC/TAF
- To evaluate changes in neurocognitive function and volumetric, spectroscopic, tractographic and cerebral perfusion markers, acquired by Magnetic Resonance Imaging, after switching from DTG/3TC/ABC to ELV/COBI/FTC/TAF
- Percentages of virologic failure
|
64 |
All |
18 Years and older (Adult, Older Adult) |
NCT03067285 |
GESIDA 9016 |
DREAM |
September 8, 2017 |
September 1, 2018 |
December 1, 2018 |
March 1, 2017 |
May 28, 2018 |
|
- Hospital Puerta de Hierro
Majadahonda, Madrid, Spain - Hospital Clínico San Carlos
Madrid, Spain - Hospital Fundación Jimenez Díaz
Madrid, Spain - (and 4 more...)
|
|
| 42 |
NCT01766726 |
Completed |
Effects of Newly-Initiated QUAD Therapy on Aortic/Coronary Inflammation in ART-Naïve Infected Patients |
|
|
Observational
|
|
- Massachusetts General Hospital
- Gilead Sciences
|
Other / Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Aortic/coronary target to background ratio (TBR) on cardiac FDG-PET
- Aortic/coronary atherosclerotic plaque on coronary computed tomography angiography (coronary CTA)
- Lipid and lipoprotein levels
- (and 3 more...)
|
33 |
All |
18 Years and older (Adult, Older Adult) |
NCT01766726 |
2012P001138 |
Quad |
December 2012 |
January 2016 |
January 2016 |
January 11, 2013 |
March 17, 2017 |
|
- Massachusetts General Hospital
Boston, Massachusetts, United States
|
|
| 43 |
NCT02475135 |
Completed |
Relative Bioavailability and Food Effect for Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination |
|
- Drug: Darunavir/Cobicistat/Emtricitabine/Tenofovir alafenamide FDC
- Drug: Elvitegravir /Cobicistat/Emtricitabine/Tenofovir alafenamide FDC
- Drug: Darunavir
- (and 4 more...)
|
Interventional
|
Phase 1 |
- Janssen Sciences Ireland UC
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum Observed Plasma Concentration (Cmax) of Darunavir (DRV), cobicistat (COBI), Emtricitabine (FTC) and Tenofovir Alafenamide (TAF)
- Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) of Darunavir (DRV), cobicistat (COBI), Emtricitabine (FTC) and Tenofovir Alafenamide (TAF)
- Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of Darunavir (DRV), cobicistat (COBI), Emtricitabine (FTC) and Tenofovir Alafenamide (TAF)
- Number of Subjects with Adverse Events
|
72 |
All |
18 Years to 55 Years (Adult) |
NCT02475135 |
CR107430
2015-001213-27
TMC114FD2HTX1002 |
|
June 1, 2015 |
August 14, 2015 |
August 14, 2015 |
June 18, 2015 |
October 17, 2017 |
|
|
|
| 44 |
NCT03205696 |
Recruiting |
Prevention and Treatment Continuum for Youth at HIV Risk, Acutely Infected and With Established HIV Infection |
- Human Immunodeficiency Virus
|
|
Observational
|
|
- University of California, Los Angeles
- Los Angeles LGBT Center
- Tulane University
|
Other |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
- Amount of cell-associated HIV-1 DNA
- Evaluate HIV-1-specific CD4+ and CD8+ T-cells
- Assess the amount of unspliced HIV-1 RNA
- (and 4 more...)
|
72 |
All |
12 Years to 24 Years (Child, Adult) |
NCT03205696 |
ATNAcuteInfection |
|
August 1, 2017 |
June 20, 2019 |
June 20, 2019 |
July 2, 2017 |
October 26, 2017 |
|
- University of California, Los Angeles
Los Angeles, California, United States - Los Angeles LGBT Center
Los Angeles, California, United States - Tulane University
New Orleans, Louisiana, United States
|
|
| 45 |
NCT02276612 |
Completed
Has Results |
Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Adolescents |
|
|
Interventional
|
Phase 2
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of Treatment-Emergent Serious Adverse Events
- Incidence of Treatment-Emergent Adverse Events
- Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL at Week 24 (FDA-defined Snapshot Analysis)
- (and 5 more...)
|
60 |
All |
12 Years to 17 Years (Child) |
NCT02276612 |
GS-US-292-1515
2014-002673-11 |
|
December 3, 2014 |
November 10, 2016 |
October 23, 2017 |
October 28, 2014 |
February 22, 2018 |
February 22, 2018 |
- Tampa, Florida, United States
- Detroit, Michigan, United States
- New York, New York, United States
- (and 4 more...)
|
|
| 46 |
NCT01818596 |
Active, not recruiting
Has Results |
Open-label Safety Study of E/C/F/TAF (Genvoya®) in HIV-1 Positive Patients With Mild to Moderate Renal Impairment |
|
|
Interventional
|
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change From Baseline in the Estimated Glomerular Filtration Rate Calculated by the Cockcroft-Gault Formula (eGFR_CG) at Week 24
- Change From Baseline in eGFR Calculated by the Chronic Kidney Disease Epidemiology Collaboration Method Based on Cystatin C (eGFR_CKD-EPI,cysC) at Week 24
- Change From Baseline in eGFR Calculated by the CKD-EPI Method Based on Serum Creatinine (eGFR_CKD-EPI,Creatinine) at Week 24
- (and 15 more...)
|
252 |
All |
18 Years and older (Adult, Older Adult) |
NCT01818596 |
GS-US-292-0112
2013-000516-25 |
|
March 27, 2013 |
July 31, 2014 |
September 2018 |
March 26, 2013 |
March 21, 2018 |
February 18, 2016 |
- Maricopa Integrated Health System - McDowell Clinic
Phoenix, Arizona, United States - Spectrum Medical Group
Phoenix, Arizona, United States - Pueblo Family Physicians
Phoenix, Arizona, United States - (and 114 more...)
|
|
| 47 |
NCT02859558 |
Recruiting |
Early ART to Limit Infection and Establishment of Reservoir |
|
- Drug: elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy
|
Interventional
|
Phase 2 |
- AIDS Clinical Trials Group
- National Institute of Allergy and Infectious Diseases (NIAID)
|
Other / NIH |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Cell-associated HIV-1 DNA (CAHD) in 5 million blood-derived CD4+ T-cells assayed by qPCR
- HIV-1-specific CD4+ and CD8+ T-cell responses by flow cytometry
- Cell-associated HIV-1 RNA in 5 million blood-derived CD4+ T-cells assayed by qPCR
- Cell-associated HIV-1 RNA/DNA ratio in 5 million blood-derived CD4+ T-cells assayed by qPCR
|
150 |
All |
18 Years and older (Adult, Older Adult) |
NCT02859558 |
ACTG A5354
2UM1AI068636 |
EARLIER |
January 2017 |
July 2019 |
December 2019 |
August 9, 2016 |
February 22, 2018 |
|
- 31788 Alabama CRS
Birmingham, Alabama, United States - UCLA CARE Center CRS (601)
Los Angeles, California, United States - Ucsd, Avrc Crs (701)
San Diego, California, United States - (and 25 more...)
|
|
| 48 |
NCT02605954 |
Completed |
Safety and Efficacy of Switching From Regimens of ABC/3TC + a 3rd Agent to E/C/F/TAF Fixed-Dose Combination (FDC) in Virologically-Suppressed HIV 1 Infected Adults |
|
- Drug: E/C/F/TAF
- Drug: ABC/3TC
- Drug: Third Antiretroviral Agent
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Proportion of participants who have HIV-1 RNA < 50 copies/mL as defined by the FDA snapshot algorithm at Week 24
- Proportion of participants who have HIV-1 RNA < 50 copies/mL as defined by the FDA snapshot algorithm at Weeks 12 and 48
- Changes from baseline in CD4+ cell count at Weeks 24 and 48
|
275 |
All |
18 Years and older (Adult, Older Adult) |
NCT02605954 |
GS-US-292-1823
2015-002711-15 |
|
November 18, 2015 |
June 14, 2017 |
January 24, 2018 |
November 17, 2015 |
February 7, 2018 |
|
- Spectrum Medical Group
Phoenix, Arizona, United States - Ruane Clinical Research Group
Los Angeles, California, United States - Capital Medical Associates, P.C.
Washington, District of Columbia, United States - (and 46 more...)
|
|
| 49 |
NCT03493568 |
Recruiting |
Switch From Dual Regimens Based on Dolutegravir Plus a Reverse Transcriptase Inhibitor to E/C/F/TAF in Virologically Suppressed, HIV-1 Infected Patients (Be-OnE) |
|
- Drug: Genvoya 150Mg-150Mg-200Mg-10Mg Tablet
- Drug: Dolutegravir 50 mg plus one RTI
|
Interventional
|
Phase 3 |
- Ospedale San Raffaele
- Gilead Sciences
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Residual Viremia
- virological rebound
- viral reservoir
- (and 4 more...)
|
100 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT03493568 |
Be-OnE Study |
Be-OnE |
February 6, 2017 |
March 20, 2018 |
July 31, 2020 |
April 10, 2018 |
April 12, 2018 |
|
- Ospedale San Raffaele
Milan, Lombardia, Italy - Ospedale San Raffaele Scientific Institute
Milan, Italy
|
|
| 50 |
NCT01815736 |
Active, not recruiting
Has Results |
Switching From a TDF-Containing Combination Regimen to a TAF-Containing Fixed Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Positive Participants |
|
- Drug: E/C/F/TAF
- Drug: E/C/F/TDF
- Drug: EFV/FTC/TDF
- (and 4 more...)
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
- Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48
- Percent Change From Baseline in Spine BMD at Week 48
- (and 2 more...)
|
1443 |
All |
18 Years and older (Adult, Older Adult) |
NCT01815736 |
GS-US-292-0109
2012-005114-20 |
|
March 27, 2013 |
March 16, 2015 |
June 2018 |
March 21, 2013 |
March 6, 2018 |
April 14, 2016 |
- University of Alabama at Birmingham
Birmingham, Alabama, United States - Southwest Center for HIV/AIDS
Phoenix, Arizona, United States - Spectrum Medical Group
Phoenix, Arizona, United States - (and 164 more...)
|
|
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