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DTG

DRUG14 trials

Sponsors

ViiV Healthcare, Gilead Sciences, Shanxi Kangbao Biological Product Co., Ltd.

Conditions

HIVHIV InfectionsHIV-1 InfectionHIV-1-infectionHIV-1/HBV Co-InfectionInfection, Human Immunodeficiency Virus

Phase 1

A Study to Evaluate the Effect of Boceprevir and Telaprevir on Dolutegravir Pharmacokinetics in Healthy Adult Subjects (ING115697).
CompletedNCT01563328
ViiV HealthcareInfection, Human Immunodeficiency Virus
Start: 2012-03-01End: 2012-05-01Updated: 2017-03-28
Effect of Carbamazepine on Dolutegravir Pharmacokinetics in Healthy Adult Subjects
CompletedNCT01967771
ViiV HealthcareInfection, Human Immunodeficiency Virus
Start: 2013-10-31End: 2014-01-31Updated: 2014-01-27
Study to Evaluate the Drug Interaction Between Dolutegravir (DTG) and Daclatasvir (DCV) in Healthy Adult Subjects
CompletedNCT02082808
ViiV HealthcareInfection, Human Immunodeficiency Virus
Start: 2014-03-31End: 2014-05-31Updated: 2014-06-09
Bioequivalence Study of a Fixed-dose Combination (FDC) of Dolutegravir (DTG) and Rilpivirine (RPV)
CompletedNCT02741557
ViiV HealthcareHIV Infections, Infection, Human Immunodeficiency Virus
Start: 2016-05-11End: 2016-10-24Updated: 2019-07-15
Study to Evaluate the Pharmacokinetic (PK) Interactions Between GSK3640254 and Dolutegravir (DTG)
CompletedNCT03816696
ViiV HealthcareHIV Infections
Start: 2019-01-23End: 2019-04-10Updated: 2020-03-19
A Relative Bioavailability and Food-Effect Study of the Fixed Dose Combination of GSK3640254 and Dolutegravir (DTG) in Healthy Participants
CompletedNCT04857892
ViiV HealthcareHIV Infections
Start: 2021-04-21End: 2021-09-10Updated: 2024-03-12

Phase 2

Safety and Efficacy of Bictegravir + Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
CompletedNCT02397694
Gilead SciencesHIV-1 Infection
Start: 2015-03-23End: 2019-02-27Updated: 2020-04-07
Phase 2b, Open-label, Multicenter, Rollover Study to Assess Antiviral Activity and Safety of Long-acting (LA) Cabotegravir (CAB) Plus LA Rilpivirine (RPV), Administered Every 2 Months (Q2M), in Human Immunodeficiency Virus (HIV)-Positive Participants From the LATTE Study
CompletedNCT03639311
ViiV HealthcareHIV Infections
Start: 2018-09-24End: 2023-01-30Updated: 2024-06-11
Assess the Effectiveness and Safety of Lipovirtide Combined With Nucleoside Drugs in HIV-infected Patients.
CompletedNCT06061536
Shanxi Kangbao Biological Product Co., Ltd.HIV
Start: 2023-11-02End: 2025-01-24Updated: 2026-05-13

Phase 3

Comparative Efficacy and Safety Study of Dolutegravir and Lopinavir/Ritonavir in Second-line Treatment
CompletedNCT02227238
ViiV HealthcareHIV Infections
Start: 2014-12-11End: 2022-02-14Updated: 2023-03-13
Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in Human Immunodeficiency Virus (HIV-1) Infected, Antiretroviral Treatment-Naive Adults
CompletedNCT02607956
Gilead SciencesHIV-1 Infection
Start: 2015-11-11End: 2021-07-05Updated: 2022-03-07
Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Adults Who Are Virologically Suppressed
CompletedNCT03110380
Gilead SciencesHIV-1-infection
Start: 2017-06-12End: 2021-02-10Updated: 2022-01-11
Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naive, HIV-1 and Hepatitis B Co-Infected Adults
CompletedNCT03547908
Gilead SciencesHIV-1/HBV Co-Infection
Start: 2018-05-30End: 2024-03-07Updated: 2025-03-19

Unknown Phase

Study to Define Safety and Effectiveness of Dolutegravir (DTG) Use in Human Immunodeficiency Virus (HIV) Positive Pregnant Women
RecruitingNCT03564613
ViiV HealthcareHIV Infections
Start: 2019-11-18End: 2024-10-30Target: 250Updated: 2024-05-17

Related Papers

B/F/TAF in people with both HIV-1 and hepatitis B: outcomes from the ALLIANCE open-label extension phase
AIDS Research and Therapy2026-07-16
Brief Report: HIV-1 Resistance Analysis of Participants With HIV-1 and Hepatitis B Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide or Dolutegravir Plus Emtricitabine/Tenofovir Disoproxil Fumarate Through the Open-Label Extension of the ALLIANCE Study.
2025-12-01
Advances in HIV Treatment and Vaccine Development: Emerging Therapies and Breakthrough Strategies for Long-Term Control.
2025-07-041 citations
Long-term metabolic changes with bictegravir/emtricitabine/tenofovir alafenamide or dolutegravir-containing regimens for HIV.
2025-04-071 citations
Efficacy and safety of bictegravir/emtricitabine/tenofovir alafenamide in Black and Hispanic/Latine adults with <scp>HIV</scp>‐1 initiating first‐line therapy: 5‐year follow‐up from two phase III studies
HIV Medicine2025-03-21
P-547. Efficacy and Safety of B/F/TAF in Treatment-Naïve People With HIV Aged ≥ 50 Years: 5-Year Follow-Up From Two Phase 3 Studies
Open Forum Infectious Diseases2025-01-29
P-550. Efficacy and Safety of B/F/TAF in Black Adults with HIV Who Are Treatment Naïve: 5-Year Follow-Up from Two Phase 3 Studies
Open Forum Infectious Diseases2025-01-29
Efficacy of bictegravir/emtricitabine/tenofovir alafenamide versus dolutegravir-based three-drug regimens in people with HIV with varying adherence to antiretroviral therapy
UNC Libraries2024-12-04
Efficacy of bictegravir/emtricitabine/tenofovir alafenamide versus dolutegravir-based three-drug regimens in people with HIV with varying adherence to antiretroviral therapy
Journal of Antimicrobial Chemotherapy2024-11-185 citations
Two 5-year studies of bictegravir/emtricitabine/tenofovir alafenamide in people with HIV: a plain-language summary
Future Microbiology2024-09-041 citations
Brief Report: HIV-1 Resistance Analysis of Participants With HIV-1 and Hepatitis B Initiating Therapy With Bictegravir/Emtricitabine/Tenofovir Alafenamide or Dolutegravir Plus Emtricitabine/Tenofovir Disoproxil Fumarate: A Subanalysis of ALLIANCE Data
JAIDS Journal of Acquired Immune Deficiency Syndromes2024-04-253 citations
Switch to bictegravir/emtricitabine/tenofovir alafenamide from dolutegravir-based therapy
AIDS2024-02-1311 citations
Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, emtricitabine, and tenofovir disoproxil fumarate for initial treatment of HIV-1 and hepatitis B coinfection (ALLIANCE): a double-blind, multicentre, randomised controlled, phase 3 non-inferiority trial.
2023-07-2333 citations
Bictegravir/emtricitabine/tenofovir alafenamide as initial treatment for HIV-1: five-year follow-up from two randomized trials.
2023-05-1162 citations
875. Indirect Treatment Comparison of 48-Week Efficacy and Safety of Cabotegravir + Rilpivirine Long-Acting Every 2 Months to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Suppressed HIV-1 Infected Participants
Open Forum Infectious Diseases2021-11-01
Integrase Inhibitor Resistance Mechanisms and Structural Characteristics in Antiretroviral Therapy-Experienced, Integrase Inhibitor-Naive Adults with HIV-1 Infection Treated with Dolutegravir plus Two Nucleoside Reverse Transcriptase Inhibitors in the DAWNING Study.
2021-10-2528 citations
Long-acting cabotegravir and rilpivirine for HIV-1 suppression: switch to 2-monthly dosing after 5 years of daily oral therapy
AIDS2021-10-1334 citations
Switching to Bictegravir, Emtricitabine, and Tenofovir Alafenamide in Virologically Suppressed Adults With Human Immunodeficiency Virus
Clinical Infectious Diseases2020-07-10103 citations
Fixed-dose combination bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir-containing regimens for initial treatment of HIV-1 infection: week 144 results from two randomised, double-blind, multicentre, phase 3, non-inferiority trials.
2020-06-01101 citations
2840. Long-term Efficacy, Safety, and Durability of CAB and RPV as Two Drug Oral Maintenance Therapy: LATTE Week 312 Results
Open Forum Infectious Diseases2019-10-018 citations

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