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Infection, Human Immunodeficiency Virus

109
Pipeline Programs
3
Companies
50
Clinical Trials
2
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
68
0
19
0
15
7
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
31100%
+ 166 programs with unclassified modality

On Market (2)

Approved therapies currently available

GSK
APRETUDEApproved
cabotegravir
GSK
intramuscular2021
11M Part D
GSK
EPIVIRApproved
lamivudine
GSK
Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]oral1995
103K Part D

Competitive Landscape

3 companies ranked by most advanced pipeline stage

ViiV Healthcare
ViiV HealthcareNC - Durham
101 programs
60
16
12
5
Dolutegravir 50 mgPhase 4
GI265235Phase 4
LamivudinePhase 4
Reyataz + Norvir + TruvadaPhase 4
fosamprenavirPhase 4Small Molecule
+96 more programs
GSK
GSKLONDON, United Kingdom
82 programs
1
Cheek swab & blood testN/A1 trial
Continued Access ArmN/A1 trial
DolutegravirN/ASmall Molecule1 trial
DolutegravirN/ASmall Molecule1 trial
Exposure to licensed dose of FPVN/A1 trial
+77 more programs
Active Trials
NCT00453440Completed1,502Est. Aug 2007
NCT01776996No Longer Available
NCT01536873Completed200Est. Sep 2016
+79 more trials
Shionogi
ShionogiJapan - Osaka
14 programs
8
3
3
DolutegravirPhase 3Small Molecule
GSK1349572Phase 3
dolutegravirPhase 3Small Molecule
GSK1265744 30mgPhase 2
GSK1349572Phase 2
+9 more programs

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
GSKDolutegravir 50 mg
GSKLamivudine
GSKReyataz + Norvir + Truvada
GSKGI265235
GSKfosamprenavir
GSKCabotegravir
GSKDolutegravir
GSKDolutegravir
GSKDTG 50 mg
GSKDTG 50 mg /ABC 600 mg /3TC 300 mg FDC tablets
GSKABC/DTG/3TC FDC
GSKDolutegravir/abacavir/lamivudine FDC
GSKDolutegravir
GSKdolutegravir 50 mg OAD
GSKdolutegravir

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 8,264 patients across 50 trials

NCT03314064GSKDolutegravir 50 mg

Phase 4 Study of Dolutegravir (DTG) in Russian Federation

Start: Dec 2016Est. completion: Oct 201843 patients
Phase 4Completed
NCT02634073GSKLamivudine

A Phase IV, Open Label, 4-period Cross-over Study to Investigate a Drug Interaction Between Lamivudine and Sorbitol Oral Solutions in Healthy Volunteers

Start: Jan 2016Est. completion: Mar 201616 patients
Phase 4Completed
NCT01102972GSKReyataz + Norvir + Truvada

A Simplification Study of Unboosted Reyataz With Epzicom (ASSURE)

Start: Apr 2010Est. completion: Dec 2012297 patients
Phase 4Completed

Prospective Epidemiological Study Of The Prevalence Of HLAB*5701 In HIV-1 Infected Patients

Start: Mar 2007Est. completion: Jun 2007974 patients
Phase 4Completed
NCT00240552GSKfosamprenavir

Fosamprenavir Expanded Access

Start: Jul 2003Est. completion: Aug 200585 patients
Phase 4Completed
NCT02951052GSKCabotegravir

Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current Antiretroviral Regimen in Virologically Suppressed HIV-1-infected Adults

Start: Oct 2016Est. completion: Dec 2029618 patients
Phase 3Active Not Recruiting
NCT02831673GSKDolutegravir

An Efficacy, Safety, and Tolerability Study Comparing Dolutegravir Plus Lamivudine With Dolutegravir Plus Tenofovir/Emtricitabine in Treatment naïve HIV Infected Subjects (Gemini 1)

Start: Jul 2016Est. completion: Aug 2022719 patients
Phase 3Completed
NCT02831764GSKDolutegravir

An Efficacy, Safety, and Tolerability Study Comparing Dolutegravir (DTG) Plus Lamivudine (3TC) With Dolutegravir Plus Tenofovir/Emtricitabine in Treatment naïve HIV Infected Participants (Gemini 2)

Start: Jul 2016Est. completion: Jun 2022722 patients
Phase 3Completed

Open-label Study of Dolutegravir (DTG) or Efavirenz (EFV) for Human Immunodeficiency Virus (HIV) - Tuberculosis (TB) Co-infection

Start: Jan 2015Est. completion: Mar 2020113 patients
Phase 3Completed
NCT02075593GSKDTG 50 mg /ABC 600 mg /3TC 300 mg FDC tablets

ING200336, Pharmacokinetic and Safety Study in Pregnant Women With Human Immuno Virus Infection

Start: Dec 2014Est. completion: Sep 20214 patients
Phase 3Completed
NCT02105987GSKABC/DTG/3TC FDC

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

Start: Apr 2014Est. completion: Dec 2015555 patients
Phase 3Completed
NCT01910402GSKDolutegravir/abacavir/lamivudine FDC

A Study to Determine Safety and Efficacy of Dolutegravir/Abacavir/Lamivudine (DTG/ABC/3TC) in Human Immunodeficiency Virus (HIV)-1 Infected Antiretroviral Therapy (ART) Naïve Women (ARIA)

Start: Aug 2013Est. completion: Aug 2022499 patients
Phase 3Completed
NCT01499199GSKDolutegravir

A Study of the Pharmacokinetics and Antiviral Activity of Dolutegravir in the Central Nervous System in HIV-1 Infected ART-naive Subjects

Start: Jan 2012Est. completion: May 201413 patients
Phase 3Completed
NCT01449929GSKdolutegravir 50 mg OAD

Dolutegravir Compared to Darunavir/Ritonavir , Each in Combination With Dual Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in ART-naive Subjects

Start: Oct 2011Est. completion: Dec 2016488 patients
Phase 3Completed
NCT01328041GSKdolutegravir

A Study to Assess Dolutegravir in HIV-infected Subjects With Treatment Failure on an Integrase Inhibitor Containing Regimen.

Start: May 2011Est. completion: May 2015183 patients
Phase 3Completed
NCT00296504GSKfosamprenavir

A Study To Assess GW433908 (Fosamprenavir) Containing Regimens In HIV-1 Infected Subjects

Start: Nov 2001Est. completion: Oct 2010753 patients
Phase 3Completed
NCT03045861GSKGSK2838232

Safety and Efficacy Study of GSK2838232 in Human Immunodeficiency Virus (HIV)-1 Infected Adults

Start: Mar 2017Est. completion: Apr 201833 patients
Phase 2Completed
NCT02415595GSKBMS-955176

Dose-finding Study of BMS-955176 to Treat HIV-1 Infected Treatment-naive Adults

Start: May 2015Est. completion: Aug 2017210 patients
Phase 2Terminated
NCT02120352GSKCAB Oral Tablets

A Phase IIb Study to Evaluate a Long-Acting Intramuscular Regimen for Maintenance of Virologic Suppression (Following Induction With an Oral Regimen of GSK1265744 and Abacavir/Lamivudine) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected, Antiretroviral Therapy-Naive Adult Subjects

Start: Apr 2014Est. completion: Apr 2023309 patients
Phase 2Completed
NCT01384734GSKBMS-663068 400 mg

HIV Attachment Inhibitor to Treat Human Immunodeficiency Virus 1 (HIV-1) Infections

Start: Jul 2011Est. completion: May 2017254 patients
Phase 2Completed
NCT01231555GSKGSK2248761 100 mg once daily

Dose-finding Study of GSK2248761 in Antiretroviral Therapy-Naive Subjects (SIGNET)

Start: Nov 2010Est. completion: Jul 201123 patients
Phase 2Terminated
NCT01199731GSKGSK2248761 100 mg once daily

Dose-finding Study of GSK2248761 in Antiretroviral Therapy-experienced Subjects With NNRTI-resistant HIV Infection

Start: Oct 2010Est. completion: Jul 201130 patients
Phase 2Terminated
NCT00950859GSKGSK1349572

A Pilot Study Assessing the Integrase Inhibitor GSK1349572 in HIV-infected Persons With Virus Resistant to Raltegravir

Start: Aug 2009Est. completion: Jan 201551 patients
Phase 2Completed
NCT00951015GSKGSK1349572

A Dose Ranging Trial of GSK1349572 and 2 NRTI in HIV-1 Infected, Therapy Naive Subjects

Start: Jul 2009Est. completion: Dec 2016208 patients
Phase 2Completed

Study Of An Investigational Regimen Including FDA Approved HIV Drugs In HIV-Infected Pediatric Subjects

Start: Oct 2003Est. completion: Mar 202259 patients
Phase 2Completed
NCT03149848GSKCabotegravir

Effect of Rifabutin on the Pharmacokinetics of Oral Cabotegravir in Healthy Subjects

Start: Jun 2017Est. completion: Sep 201715 patients
Phase 1Completed
NCT03078556GSKDolutegravir

Bioequivalence Study of Fixed Dose Versus Single Entities of Dolutegravir and Lamivudine

Start: Mar 2017Est. completion: Aug 2017154 patients
Phase 1Completed
NCT02478463GSKCabotegravir tablet 30 mg once daily for 28 days.

Pharmacokinetic Study of Cabotegravir Long-acting in Healthy Adult Volunteers

Start: Feb 2017Est. completion: Jul 201919 patients
Phase 1Completed
NCT02893488GSKDTG/ABC/3TC FDC DISPERSIBLE TABLET

Relative Bioavailability Study of a Fixed-dose Combination Dolutegravir/Abacavir/Lamivudine Dispersible Tablet

Start: Sep 2016Est. completion: Nov 201620 patients
Phase 1Completed
NCT02859259GSKBMS-663068

A Study of the Relative Bioavailability of BMS-626529 Administered as BMS-663068 From 150mg Low-dose Extended-release Tablets Compared to 600mg Reference Extended-release Tablets in Healthy Subjects

Start: Aug 2016Est. completion: Aug 201614 patients
Phase 1Completed
NCT02799264GSKCabotegravir 30 mg

A Study to Evaluate the Effect of High Fat Meal on Cabotegravir

Start: Jun 2016Est. completion: Aug 201624 patients
Phase 1Completed

Bioequivalence Study of a Fixed-dose Combination (FDC) of Dolutegravir (DTG) and Rilpivirine (RPV)

Start: May 2016Est. completion: Oct 2016118 patients
Phase 1Completed
NCT02738931GSKDolutegravir 50 mg tablet

Relative Bio-availability Study of Dolutegravir and Lamivudine Fixed Dose Combinations

Start: May 2016Est. completion: Jun 201630 patients
Phase 1Completed
NCT02715479GSKDolutegravir

A Study to Evaluate the Effect of BMS-955176 on Pharmacokinetics of Dolutegravir and the Effect of Dolutegravir on the Pharmacokinetics of BMS-955176

Start: Apr 2016Est. completion: May 201614 patients
Phase 1Completed
NCT02805556GSKBMS-663068

Absolute Bioavailability of BMS-626529 After Oral and Intravenous Dosing

Start: Mar 2016Est. completion: May 201636 patients
Phase 1Completed
NCT02666053GSKBMS-663068

A Study to Assess the Effect of High Fat Meal and Increased Gastric pH on the Bioavailability of an Extended Release Formulation of BMS-663068 in Healthy Subjects

Start: Jan 2016Est. completion: Feb 201672 patients
Phase 1Completed
NCT02666001GSKBMS-663068

A Study to Assess the Drug-drug Interaction of BMS 663068 With Methadone and Also With Buprenorphine/Naloxone

Start: Jan 2016Est. completion: Jun 201632 patients
Phase 1Completed
NCT02539576GSKABC/DTG/3TC FDC tablet

Pharmacokinetics, Safety and Tolerability Study of Abacavir/ Dolutegravir/ Lamivudine Fixed-dose Combination Tablets in Healthy Japanese Subjects

Start: Oct 2015Est. completion: Nov 201512 patients
Phase 1Completed
NCT02508064GSKBMS-663068

Bioavailability of BMS-626529 in Healthy Subjects From Prototype Low Dose Extended Release Formulations (Part 1) and Prototype Extended Release Multi-particulate Formulations (Part 2) of BMS-663068 Relative to 600 mg Extended Release Tablet

Start: Aug 2015Est. completion: Nov 201527 patients
Phase 1Completed
NCT02354937GSKGSK1265744 30 mg

Pharmacokinetics Study of GSK1265744 in Subjects With Severe Renal Impairment

Start: Jul 2015Est. completion: Nov 201616 patients
Phase 1Completed
NCT02480881GSKBMS-663068

A Drug-drug Interaction Study Between BMS-663068 and Oral Contraceptives in Healthy Female Volunteers (DDI)

Start: Jul 2015Est. completion: Jan 201626 patients
Phase 1Completed
NCT02480894GSKBMS-663068

A Open-label, Drug-Drug Interaction With Maraviroc (DDI)

Start: Jul 2015Est. completion: Sep 2015112 patients
Phase 1Completed

Effect of Rifampin (RIF) on the Pharmacokinetics (PK) of Oral Cabotegravir (CAB) in Healthy Subjects

Start: Jul 2015Est. completion: Sep 201515 patients
Phase 1Completed
NCT02345707GSKCabotegravir 30 mg current formulation

Relative Bioavailability Study of Phase III Tablet Formulation of Cabotegravir

Start: Mar 2015Est. completion: Jun 201537 patients
Phase 1Completed

Relative Oral Bioavailability Study of Different Fixed Dose Combinations of Dolutegravir and Rilpivirine in Healthy Subjects

Start: Feb 2015Est. completion: Sep 201563 patients
Phase 1Completed
NCT02467335GSKBMS-663068

Single-dose Pharmacokinetics of BMS-626529, Administered as BMS-663068, in Subjects With Hepatic Impairment Compared to Healthy Subjects

Start: Jan 2015Est. completion: Oct 201552 patients
Phase 1Completed
NCT02277600GSKBMS-663068

A Phase 1 Antiretroviral Drug-Drug Interaction Study in Healthy Volunteers (DDI)

Start: Nov 2014Est. completion: Jan 201532 patients
Phase 1Completed
NCT02273947GSKBMS-955176

Food Effect Study With BMS-955176

Start: Oct 2014Est. completion: Aug 201612 patients
Phase 1Completed
NCT02185300GSKDolutegravir Pediatric Granules

Bioavailability Study of a Dolutegravir Dispersible Tablet and Effect of Different Types of Water on the Dispersible Tablet in Healthy Volunteers

Start: Jul 2014Est. completion: Sep 201415 patients
Phase 1Completed
NCT02164045GSKBMS-663068

Study to Evaluate the Effect of Food on the Pharmacokinetics of BMS-626529

Start: Jun 2014Est. completion: Jul 201438 patients
Phase 1Completed

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

15 late-stage (Phase 3) programs, potential near-term approvals
3 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.