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HIV-1 Infection

Infectious Disease 5 original drugs

Novel Drugs

Reformulations

Active Trials

Drug Targets

Infectious Disease indication. HIV-1 Infection has 5 FDA-approved novel treatments, led by Merck across 4 drug targets. Explore market leaders, treatments by mechanism, the clinical pipeline, and drug targets below.

HIV-1 Infection Market Leaders

Companies with the most FDA-approved novel HIV-1 Infection drugs.

Phase 3 Readouts Pro

6 active Phase 3 trials with confidence-graded completion dates.

Full calendar →

Q3 2027

MK-8527

Merck

Estimated · fresh NCT07044297

Q4 2027

MK-8527

Merck

Estimated · fresh NCT07071623

Q1 2029

ISL

Merck

Estimated · fresh NCT07266831

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Anchored on CT.gov primary completion date. Topline announcements typically precede this by 3–9 months. Confidence labels combine date type (ACTUAL/ESTIMATED) with last-update freshness.

HIV-1 Infection Treatments by Mechanism

Top 11 mechanisms across 42 industry trials with a known mechanism of action.

See full pipeline →

Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor

10 trials 1 active 1 sponsor

Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor

9 trials 1 active 6 sponsors

Protease Inhibitor

7 trials 4 sponsors

CCR5 Co-receptor Antagonist

6 trials 2 sponsors

Cytochrome P450 3A Inhibitor

4 trials 2 sponsors

Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor

1 trials 1 sponsor

DNA

1 trials 1 sponsor

Alkylating Drug

1 trials 1 sponsor

Thalidomide Analog

1 trials 1 sponsor

Azole Antifungal

1 trials 1 sponsor

CD30-directed Immunoconjugate

1 trials 1 sponsor

MoA derived from FDA pharmClassEpc when intervention matches an approved drug. Codenamed clinical-stage assets without an approved counterpart show "—" and aren't grouped here — they're still in the phase tables below.

HIV-1 Infection Clinical Pipeline by Phase

399 industry-sponsored trials across 69 sponsors

Showing 17 of 17 trials

Sponsor	Asset	MoA	Status	Primary Completion	NCT
Janssen Scientific Affairs, LLC	D/C/F/TAF FDC	—	COMPLETED	2023-08-07	NCT04442737
Napo Pharmaceuticals, Inc.	Crofelemer delayed-release tablets 125mg	—	COMPLETED	2021-08-31	NCT04192487
Merck	Raltegravir	—	COMPLETED	2018-10-23	NCT03667547
ViiV Healthcare	Dolutegravir 50 mg	—	COMPLETED	2018-10-01	NCT03314064
ViiV Healthcare	Lamivudine	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]	COMPLETED	2016-03-01	NCT02634073
Gilead	STB	—	COMPLETED	2016-01-20	NCT02246998
Janssen R&D Ireland	Etravirine	Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]	COMPLETED	2013-11	NCT01422330
ViiV Healthcare	HIV therapy	—	COMPLETED	2012-10	NCT01275625
Johnson & Johnson	TMC114/ritonavir	—	COMPLETED	2012-06	NCT01702090
ViiV Healthcare	Reyataz + Norvir + Truvada	—	COMPLETED	2012-06	NCT01102972
Bristol-Myers Squibb	Atazanavir	—	COMPLETED	2011-06	NCT01232127
Gilead	emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)	—	COMPLETED	2011-03	NCT00724711
Gilead	Truvada + Kaletra	—	COMPLETED	2009-09	NCT00772902
Tibotec, Inc	ritonavir	Cytochrome P450 3A Inhibitor [EPC]	COMPLETED	2009-08	NCT00757783
ViiV Healthcare	Maraviroc	CCR5 Co-receptor Antagonist [EPC]	COMPLETED	2008-11	NCT00717067
Theratechnologies	Tesamorelin	—	TERMINATED	2018-05	NCT01591902
ViiV Healthcare	maraviroc	CCR5 Co-receptor Antagonist [EPC]	WITHDRAWN	2010-02	NCT00782301

Showing 100 of 109 trials (top 100 by completion date — export for full list)

Sponsor	Asset	MoA	Status	Primary Completion	NCT
Merck	MK-8527	—	RECRUITING	2027-07-22	NCT07044297
Merck	MK-8527	—	RECRUITING	2027-10-18	NCT07071623
Merck	ISL	—	RECRUITING	2029-03-21	NCT07266831
Merck	MK-8591A	—	ACTIVE NOT RECRUITING	2029-05-29	NCT04776252
ViiV Healthcare	Dolutegravir	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]	ACTIVE NOT RECRUITING	2026-04-15	NCT05979311
Merck	DOR/ISL	—	ACTIVE NOT RECRUITING	2025-10-16	NCT05766501
Merck	DOR/ISL	—	ACTIVE NOT RECRUITING	2025-10-13	NCT05705349
Gilead	B/F/TAF (Adult Strength)	—	ACTIVE NOT RECRUITING	2025-03-24	NCT02881320
Merck	DOR/ISL	—	ACTIVE NOT RECRUITING	2024-10-25	NCT05630755
Merck	ART	—	ACTIVE NOT RECRUITING	2024-10-10	NCT05631093
Gilead	Oral Lenacapavir (LEN)	—	ACTIVE NOT RECRUITING	2024-08-21	NCT04925752
Gilead	Oral Lenacapavir (LEN)	—	ACTIVE NOT RECRUITING	2024-05-27	NCT04994509
Gilead	F/TAF	—	ACTIVE NOT RECRUITING	2019-01-31	NCT02842086
ViiV Healthcare	Cabotegravir (CAB) tablet	—	ACTIVE NOT RECRUITING	2018-05-29	NCT02951052
United BioPharma	UB-421	—	NOT YET RECRUITING	2026-06-30	NCT04406727
ViiV Healthcare	DTG/3TC	—	COMPLETED	2026-01-23	NCT05911360
ViiV Healthcare	Cabotegravir - Injectable Suspension (CAB LA)	—	COMPLETED	2023-09-14	NCT05896748
Merck	ISL	—	COMPLETED	2022-11-21	NCT04233216
Merck	DOR/ISL	—	COMPLETED	2022-11-17	NCT04233879
ViiV Healthcare	Cabotegravir Injectable Suspension	—	COMPLETED	2022-08-23	NCT05896761
Merck	DOR/ISL	—	COMPLETED	2021-09-08	NCT04223778
Merck	DOR/ISL	—	COMPLETED	2021-08-26	NCT04223791
Johnson & Johnson	Darunavir	Protease Inhibitor [EPC]	COMPLETED	2021-07-29	NCT01281813
Johnson & Johnson	Etravirine	Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]	COMPLETED	2020-11-25	NCT00980538
CytoDyn, Inc.	PRO 140 (350 mg)	—	COMPLETED	2020-09-16	NCT02859961
Janssen R&D Ireland	Rilpivirine	—	COMPLETED	2020-02	NCT01266902
Gilead	F/TAF	—	COMPLETED	2019-11-04	NCT02285114
Gilead	B/F/TAF	—	COMPLETED	2019-08-12	NCT03631732
Sanofi	Hexaxim®: DTaP-IPV-HB-PRP-T Combined Vaccine	—	COMPLETED	2019-02-22	NCT02817451
Janssen Scientific Affairs, LLC	DRV 800 mg + COBI 150 mg + FTC 200 mg + TAF 10 mg FDC	—	COMPLETED	2019-01-03	NCT03227861
Gilead	B/F/TAF	—	COMPLETED	2018-11-20	NCT03405935
TaiMed Biologics Inc.	ibalizumab	—	COMPLETED	2018-11	NCT02707861
ViiV Healthcare	DTG 50 mg /ABC 600 mg /3TC 300 mg FDC tablets	—	COMPLETED	2018-10-22	NCT02075593
Gilead	E/C/F/TAF	—	COMPLETED	2018-10-11	NCT02616029
International Partnership for Microbicides, Inc.	—	—	COMPLETED	2018-10-10	NCT02858037
ViiV Healthcare	Dolutegravir (DTG)	—	COMPLETED	2018-04-04	NCT02831764
ViiV Healthcare	Dolutegravir (DTG)	—	COMPLETED	2018-03-29	NCT02831673
Merck	Doravirine, Tenofovir, Lamivudine	—	COMPLETED	2018-02-22	NCT02397096
Gilead	E/C/F/TAF	—	COMPLETED	2018-02-21	NCT02616783
CytoDyn, Inc.	PRO 140	—	COMPLETED	2018-02	NCT02483078
Gilead	F/TAF	—	COMPLETED	2017-12-11	NCT02469246
ViiV Healthcare	DTG 50 mg	—	COMPLETED	2017-11-02	NCT02178592
Gilead	E/C/F/TAF	—	COMPLETED	2017-10-09	NCT02652624
Gilead	E/C/F/TAF	—	COMPLETED	2017-09-29	NCT02600819
Gilead	E/C/F/TAF	—	COMPLETED	2017-09-14	NCT02707601
Gilead	E/C/F/TAF	—	COMPLETED	2017-06-14	NCT02605954
Gilead	RTV	—	COMPLETED	2017-05-15	NCT02603107
Gilead	DTG	—	COMPLETED	2017-05-12	NCT02607956
Gilead	ABC/DTG/3TC	—	COMPLETED	2017-05-09	NCT02607930
Gilead	ABC/DTG/3TC	—	COMPLETED	2017-05-09	NCT02603120
Merck	Doravirine, Tenofovir, Lamivudine	—	COMPLETED	2017-03-20	NCT02403674
AbbVie	ABT-493 coformulated with ABT-530	—	COMPLETED	2017-03-15	NCT02738138
Janssen R&D Ireland	D/C/F/TAF	—	COMPLETED	2017-02	NCT02269917
Gilead	E/C/F/TAF	—	COMPLETED	2016-11-10	NCT02276612
TaiMed Biologics Inc.	ibalizumab	—	COMPLETED	2016-10	NCT02475629
Merck	Doravirine	Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]	COMPLETED	2016-09-29	NCT02275780
Janssen Scientific Affairs, LLC	Darunavir	Protease Inhibitor [EPC]	COMPLETED	2016-08-11	NCT00855335
AbbVie	ABT-450/r/ABT-267	—	COMPLETED	2016-07-21	NCT01939197
Gilead	FTC/RPV/TAF	—	COMPLETED	2016-06-29	NCT02345226
Gilead	FTC/RPV/TAF	—	COMPLETED	2016-06-22	NCT02345252
Merck	Reformulated Raltegravir	—	COMPLETED	2015-12-21	NCT02131233
Janssen-Cilag International NV	Rilpivirine	—	COMPLETED	2015-10-22	NCT01709084
Institut Pasteur	cotrimoxazole daily prophylaxis	—	COMPLETED	2015-10	NCT01746199
ViiV Healthcare	Dolutegravir/abacavir/lamivudine FDC	—	COMPLETED	2015-09-22	NCT01910402
Biocad	Algeron	—	COMPLETED	2015-08-26	NCT02103439
Gilead	FTC/TDF	—	COMPLETED	2015-08-12	NCT02121795
Gilead	E/C/F/TAF	—	COMPLETED	2015-07-21	NCT01968551
Gilead	TAF	—	COMPLETED	2015-05-21	NCT01967940
ViiV Healthcare	ABC/DTG/3TC FDC	—	COMPLETED	2015-04	NCT02105987
Gilead	E/C/F/TAF	—	COMPLETED	2015-03-16	NCT01815736
Gilead	E/C/F/TAF	—	COMPLETED	2015-01-23	NCT02071082
Gilead	LDV/SOF	—	COMPLETED	2014-11	NCT02073656
Gilead	E/C/F/TAF	—	COMPLETED	2014-09-19	NCT01797445
Bristol-Myers Squibb	Atazanavir Sulphate	—	COMPLETED	2014-09-10	NCT01335698
Gilead	E/C/F/TAF	—	COMPLETED	2014-08-26	NCT01780506
Gilead	E/C/F/TAF	—	COMPLETED	2014-07-31	NCT01818596
Janssen-Cilag International NV	Darunavir	Protease Inhibitor [EPC]	COMPLETED	2014-06-11	NCT01448707
Gilead	Sofosbuvir	Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC]	COMPLETED	2014-04	NCT01783678
Gilead	SOF	—	COMPLETED	2013-11	NCT01667731
Janssen-Cilag G.m.b.H	Darunavir/Ritonavir (DRV/r)	—	COMPLETED	2013-08-01	NCT01516970
ViiV Healthcare	dolutegravir 50 mg OAD	—	COMPLETED	2013-04-22	NCT01449929
ViiV Healthcare	GSK1349572	—	COMPLETED	2013-02-04	NCT01231516
ViiV Healthcare	Dolutegravir	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]	COMPLETED	2012-10	NCT01499199
Gilead	FTC/RPV/TDF	—	COMPLETED	2012-09	NCT01309243
ViiV Healthcare	Dolutegravir	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]	COMPLETED	2012-05-14	NCT01263015
ViiV Healthcare	dolutegravir	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]	COMPLETED	2012-05	NCT01328041
ViiV Healthcare	GSK1349572 (dolutegravir)	—	COMPLETED	2012-02-06	NCT01227824
Gilead	FTC/RPV/TDF	—	COMPLETED	2012-01	NCT01252940
Gilead	COBI	—	COMPLETED	2011-11	NCT01108510
Gilead	Stribild	Cytochrome P450 3A Inhibitor [EPC]	COMPLETED	2011-09	NCT01106586
Chiltern Pesquisa Clinica Ltda	Focetria®	—	COMPLETED	2011-09	NCT01032408
Gilead	Stribild	Cytochrome P450 3A Inhibitor [EPC]	COMPLETED	2011-08	NCT01095796
Merck	Comparator: raltegravir	—	COMPLETED	2011-02	NCT00764946
Gilead	Elvitegravir	—	COMPLETED	2010-12	NCT00708162
Tibotec Pharmaceuticals, Ireland	TMC278	—	COMPLETED	2010-02	NCT00540449
Tibotec Pharmaceuticals, Ireland	TMC278	—	COMPLETED	2010-01	NCT00543725
Abbott	lopinavir/ritonavir (LPV/r)	—	COMPLETED	2009-11	NCT00711009
Abbott Diagnostics Division	—	—	COMPLETED	2009-10	NCT00933933
Merck	Islatravir	—	TERMINATED	2023-07-18	NCT04644029
CytoDyn, Inc.	PRO 140	—	TERMINATED	2022-06	NCT02990858

Showing 100 of 100 trials

Sponsor	Asset	MoA	Status	Primary Completion	NCT
Henan Genuine Biotech Co., Ltd.	CL-197 capsules	—	RECRUITING	2026-12	NCT07308782
Merck	Doravirine	Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]	RECRUITING	2028-11-12	NCT04375800
Shanxi Kangbao Biological Product Co., Ltd.	LP-98 20 mg	—	RECRUITING	2026-07-10	NCT07433387
Jiangsu Aidea Pharmaceutical Group Co., Ltd.	ACC017+FTC/TAF	—	RECRUITING	2025-08	NCT06719310
Code Pharma	Dispensing Codivir®	—	RECRUITING	2024-12	NCT06676410
Johnson & Johnson	Rilpivirine	—	ACTIVE NOT RECRUITING	2026-08-18	NCT02494986
Merck	ISL	—	ACTIVE NOT RECRUITING	2027-08-10	NCT06891066
Gilead	Lenacapavir Injection	—	ACTIVE NOT RECRUITING	2028-01	NCT06101342
Gilead	Lenacapavir Tablet	—	ACTIVE NOT RECRUITING	2026-07	NCT06101329
Gilead	Lenacapavir Injection	—	ACTIVE NOT RECRUITING	2026-05-28	NCT06513312
Gilead	Teropavimab	—	ACTIVE NOT RECRUITING	2024-07-02	NCT05729568
Gilead	ISL	—	ACTIVE NOT RECRUITING	2023-12-19	NCT05052996
MGB Pharma	The monoterpenoid zinc tetra-ascorbo-camphorate ("C14")	—	NOT YET RECRUITING	2025-03-15	NCT06672653
Merck	Islatravir	—	COMPLETED	2025-01-30	NCT04564547
Shanxi Kangbao Biological Product Co., Ltd.	Subjects will be randomly assigned to receive 1.25 mg, 2.5 mg, 5 mg, or 10 mg of LP-98.	—	COMPLETED	2025-01-10	NCT06560489
Merck	MK-8527	—	COMPLETED	2024-12-12	NCT06045507
Shanxi Kangbao Biological Product Co., Ltd.	Lipovirtide 10mg	—	COMPLETED	2024-11-29	NCT06061536
Johnson & Johnson	Rilpivirine	—	COMPLETED	2023-02-17	NCT04012931
United BioPharma	UB-421	—	COMPLETED	2023-02-01	NCT05056974
Sanofi	CYD Dengue Vaccine	—	COMPLETED	2023-01-19	NCT02741128
Johnson & Johnson	Rilpivirine	—	COMPLETED	2022-08	NCT00799864
Merck	Islatravir	—	COMPLETED	2022-03-18	NCT04003103
Merck	DOR/ISL	—	COMPLETED	2021-12-21	NCT04295772
Merck	Islatravir	—	COMPLETED	2021-03-08	NCT03272347
United BioPharma	UB-421(25 mg/kg) Q2W	—	COMPLETED	2020-10-15	NCT03743376
Merck	Doravirine/lamivudine/tenofovir disoproxil fumarate	—	COMPLETED	2018-11-28	NCT02629822
Janssen Vaccines & Prevention B.V.	Ad26.Mos.HIV	—	COMPLETED	2018-09	NCT02919306
Merck	Doravirine, Tenofovir, Lamivudine - Blinded	—	COMPLETED	2018-08-14	NCT02652260
Environment and Health Group, Inc.	—	—	COMPLETED	2018-06-30	NCT03810170
Sangamo Therapeutics	Cyclophosphamide	DNA	COMPLETED	2018-06	NCT02225665
GSK	GSK2838232	—	COMPLETED	2018-04-23	NCT03045861
Johnson & Johnson	Darunavir	Protease Inhibitor [EPC]	COMPLETED	2017-11-23	NCT01138605
Calimmune, Inc.	Busulfan	Alkylating Drug [EPC]	COMPLETED	2017-09	NCT01734850
Abivax S.A.	ABX464	—	COMPLETED	2017-08-30	NCT02735863
Sangamo Therapeutics	—	—	COMPLETED	2017-07-07	NCT01543152
International Partnership for Microbicides, Inc.	—	—	COMPLETED	2016-07-05	NCT02028338
United BioPharma	UB-421	—	COMPLETED	2016-07	NCT02369146
Abivax S.A.	ABX464	—	COMPLETED	2015-12	NCT02452242
Gilead	BIC	—	COMPLETED	2015-11-30	NCT02397694
ViiV Healthcare	CAB Oral Tablets	—	COMPLETED	2015-08-13	NCT02120352
ViiV Healthcare	744 Tablet	—	COMPLETED	2015-05-15	NCT02076178
International Partnership for Microbicides, Inc.	Dapivirine Vaginal Ring	—	COMPLETED	2015-04	NCT02010593
CytoDyn, Inc.	PRO 140	—	COMPLETED	2015-02-02	NCT02175680
Sangamo Therapeutics	SB-728-T	—	COMPLETED	2014-12	NCT01252641
ViiV Healthcare	BMS-955176	—	COMPLETED	2014-11-29	NCT01803074
Gilead	Simtuzumab	—	COMPLETED	2014-10-17	NCT01707472
Theravectys S.A.	THV01-1	—	COMPLETED	2014-08	NCT02054286
Bionor Immuno AS	Lenalidomide	Thalidomide Analog [EPC]	COMPLETED	2014-08	NCT01704781
Argos Therapeutics	AGS-004	—	COMPLETED	2014-08	NCT01069809
United Biomedical	Antibody UB-421	—	COMPLETED	2014-03	NCT01668043
Bionor Immuno AS	Vacc-4x	—	COMPLETED	2014-01	NCT01712256
Merck	Raltegravir Film-coated Tablet	—	COMPLETED	2013-12-11	NCT01717287
Viriom	VM-1500/Placebo	—	COMPLETED	2013-12	NCT02485509
Bionor Immuno AS	Vacc-C5/GM-CSF	—	COMPLETED	2013-11	NCT01627678
ViiV Healthcare	GSK1265744 10 mg	—	COMPLETED	2013-10-10	NCT01641809
Gilead	SOF	—	COMPLETED	2013-08	NCT01565889
ViiV Healthcare	BMS-663068 400 mg	—	COMPLETED	2013-02-18	NCT01384734
InnaVirVax	VAC-3S	—	COMPLETED	2013-02	NCT01549119
Tobira Therapeutics, Inc.	Cenicriviroc 100 mg	—	COMPLETED	2012-12	NCT01338883
Tibotec, Inc	Etravirine	Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]	COMPLETED	2012-10	NCT01199939
Genetic Immunity	DermaVir	—	COMPLETED	2011-12	NCT00711230
Pfizer	UK-453, 061	—	COMPLETED	2011-10	NCT00824421
Gilead	FTC/RPV/TDF	—	COMPLETED	2011-07	NCT01286740
Tibotec Pharmaceuticals, Ireland	Etravirine (TMC125)	—	COMPLETED	2011-05	NCT00665847
TaiMed Biologics Inc.	Ibalizumab	—	COMPLETED	2011-04	NCT00784147
Janssen-Cilag S.p.A.	Darunavir(DRV)	—	COMPLETED	2011-04	NCT01391013
International Partnership for Microbicides, Inc.	dapivirine 4789	—	COMPLETED	2011-01-08	NCT00799058
ViiV Healthcare	GSK1349572 (Cohort I)	—	COMPLETED	2010-11	NCT00950859
Tibotec Pharmaceuticals, Ireland	darunavir	Protease Inhibitor [EPC]	COMPLETED	2010-09	NCT00915655
Tibotec Pharmaceuticals, Ireland	Darunavir	Protease Inhibitor [EPC]	COMPLETED	2010-08	NCT00919854
ViiV Healthcare	maraviroc	CCR5 Co-receptor Antagonist [EPC]	COMPLETED	2010-07	NCT00827112
ViiV Healthcare	GSK1349572	—	COMPLETED	2010-02-26	NCT00951015
Janssen-Cilag International NV	etravirine (ETR, TMC125)	—	COMPLETED	2010-02	NCT00903682
Gilead	COBI	—	COMPLETED	2009-12	NCT00892437
ViiV Healthcare	GSK2248761	—	COMPLETED	2009-11-28	NCT00945282
Gilead	Stribild	Cytochrome P450 3A Inhibitor [EPC]	COMPLETED	2009-11	NCT00869557
Tobira Therapeutics, Inc.	TBR-652	—	COMPLETED	2009-11	NCT01092104
ViiV Healthcare	GSK1265744 30mg	—	COMPLETED	2009-08-13	NCT00920426
Tibotec Pharmaceuticals, Ireland	TMC310911 75 mg twice daily	—	COMPLETED	2009-08	NCT00838162
Myrexis Inc.	Bevirimat	—	COMPLETED	2009-01	NCT01097070
ViiV Healthcare	GSK1349572	—	COMPLETED	2008-08	NCT00708110
Tibotec, Inc	TMC125; darunavir; ritonavir	—	COMPLETED	2008-05	NCT00534352
CytoDyn, Inc.	PRO 140 350mg weekly subcutaneous (SC) injection.	—	TERMINATED	2022-06	NCT02355184
Janssen Vaccines & Prevention B.V.	Ad26.Mos4.HIV	—	TERMINATED	2022-02-02	NCT03060629
ViiV Healthcare	BMS-955176	—	TERMINATED	2016-05-26	NCT02415595
Pfizer	No drug will be administered	—	TERMINATED	2013-07	NCT00824369
Cytheris SA	Interleukin-7	—	TERMINATED	2013-06	NCT01190111
Cytheris SA	CYT107	—	TERMINATED	2013-06	NCT01241643
Pfizer	lersivirine	—	TERMINATED	2013-04	NCT01254656
Bristol-Myers Squibb	BMS-986001	—	TERMINATED	2013-03	NCT01489046
RFS Pharma, LLC	amdoxovir 300 mg bid	—	TERMINATED	2013-02	NCT01737359
Pfizer	UK-453,061 Dose 1	—	TERMINATED	2012-10-18	NCT00823979
ViiV Healthcare	GSK2248761 100 mg once daily	—	TERMINATED	2011-07-19	NCT01199731
ViiV Healthcare	GSK2248761 100 mg once daily	—	TERMINATED	2011-07-04	NCT01231555
Bristol-Myers Squibb	Atazanavir	—	TERMINATED	2010-01	NCT00768989
Merck	Islatravir	—	WITHDRAWN	2025-10-02	NCT05115838
Merck	Islatravir	—	WITHDRAWN	2024-03-25	NCT05130086
United BioPharma	UB-421	—	WITHDRAWN	2020-12	NCT04041362
CytoDyn, Inc.	PRO 140	—	WITHDRAWN	2017-01	NCT01272258
RFS Pharma, LLC	amdoxovir 300 mg bid	—	WITHDRAWN	2014-08	NCT01738555

Showing 100 of 173 trials (top 100 by completion date — export for full list)

Sponsor	Asset	MoA	Status	Primary Completion	NCT
Immuno Cure Holding (HK) Limited	ICVAX (TERESA-EPT I device)	—	RECRUITING	2027-03-31	NCT07530198
Merck	MK-8527	—	NOT YET RECRUITING	2027-01-19	NCT07600775
Jecho Biopharmaceuticals Co., Ltd.	JL18008	—	NOT YET RECRUITING	2029-12-20	NCT07443228
Merck	MK-4646	—	COMPLETED	2026-06-05	NCT07042945
Immuno Cure Holding (HK) Limited	ICVAX	—	COMPLETED	2024-09-30	NCT06253533
MacroGenics	MGD020	—	COMPLETED	2024-05-29	NCT05261191
Shanxi Kangbao Biological Product Co., Ltd.	LP-98 injection	—	COMPLETED	2024-04-12	NCT05933824
Merck	MK-8527	—	COMPLETED	2024-01-31	NCT05494736
Henan Genuine Biotech Co., Ltd.	1 mg CL-197 capsules	—	COMPLETED	2024-01-20	NCT05944848
Merck	MK-8527	—	COMPLETED	2023-10-11	NCT06783192
AbbVie	ABBV-382	—	COMPLETED	2023-08-14	NCT04554966
AbbVie	ABBV-181	—	COMPLETED	2023-02-27	NCT04223804
AbbVie	Budigalimab	—	COMPLETED	2022-10-11	NCT04799353
Johnson & Johnson	DRV/COBI FDC	—	COMPLETED	2022-09-23	NCT05197075
American Gene Technologies International Inc.	AGT103-T	—	COMPLETED	2022-08-15	NCT04561258
Gilead	Oral Lenacapavir	—	COMPLETED	2022-06-09	NCT04811040
United BioPharma	UB-421 SC(dB4C7C22-6 mAb)	—	COMPLETED	2022-05-25	NCT04620304
Jiangsu HengRui Medicine Co., Ltd.	SHR2150；Placebo	—	COMPLETED	2021-11-10	NCT04802811
Janssen Vaccines & Prevention B.V.	Ad26.Mos4.HIV	—	COMPLETED	2021-11-05	NCT03307915
Merck	Islatravir	—	COMPLETED	2021-09-13	NCT04515641
Merck	Islatravir	—	COMPLETED	2021-07-09	NCT04568603
Merck	Islatravir	—	COMPLETED	2020-10-19	NCT04303156
Aelix Therapeutics	DNA.HTI 0.5mL at weeks 0, 4 and 8 + MVA.HTI 0.5mL at weeks 12 and 20 (DDDMM)	—	COMPLETED	2020-07-01	NCT03204617
Merck	MK-8558	—	COMPLETED	2020-05-29	NCT03859739
Janssen Pharmaceutica N.V., Belgium	D/C/F/TAF FDC placebo	—	COMPLETED	2020-03-06	NCT04006704
Gilead	Vesatolimod	—	COMPLETED	2020-02-13	NCT03060447
Gilead	Lenacapavir	—	COMPLETED	2019-11-14	NCT03739866
Merck	MK-8527	—	COMPLETED	2019-09-26	NCT03615183
ViiV Healthcare	Cabotegravir tablet 30 mg once daily for 28 days.	—	COMPLETED	2019-07-25	NCT02478463
Merck	MK-8583	—	COMPLETED	2019-03-11	NCT03552536
Gilead	Vesatolimod	—	COMPLETED	2019-02-14	NCT02858401
Antiva Biosciences	ABI-1968	—	COMPLETED	2019-02-04	NCT03202992
Merck	MK-4250	—	COMPLETED	2018-11-02	NCT03351699
ViiV Healthcare	GSK3640254	—	COMPLETED	2018-09-09	NCT03231943
KBio Inc	MB66	—	COMPLETED	2018-07	NCT02579083
Merck	MK-8504	—	COMPLETED	2018-05-21	NCT03188523
International Partnership for Microbicides, Inc.	Dapivirine	—	COMPLETED	2018-03-03	NCT02808949
GSK	—	—	COMPLETED	2018-01-30	NCT03368053
GSK	GSK2838232 100 mg tablet	—	COMPLETED	2017-11-10	NCT03234036
ViiV Healthcare	Cabotegravir	—	COMPLETED	2017-09-06	NCT03149848
ViiV Healthcare	Dolutegravir	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]	COMPLETED	2017-08-18	NCT03078556
Johnson & Johnson	DRV/COBI FDC placebo tablet	—	COMPLETED	2017-05-25	NCT02993237
Merck	1 mg islatravir	—	COMPLETED	2017-05-11	NCT02217904
GSK	GSK2838232 PIB	—	COMPLETED	2016-12	NCT02795754
ViiV Healthcare	GSK1265744 30 mg	—	COMPLETED	2016-11-01	NCT02354937
ViiV Healthcare	DTG/ABC/3TC FDC DISPERSIBLE TABLET	—	COMPLETED	2016-11-01	NCT02893488
ViiV Healthcare	DTG	—	COMPLETED	2016-10-24	NCT02741557
International Partnership for Microbicides, Inc.	DS003 vaginal tablet	—	COMPLETED	2016-08-26	NCT02877979
ViiV Healthcare	BMS-955176	—	COMPLETED	2016-08-15	NCT02273947
ViiV Healthcare	BMS-663068 (1 tablet at 600 mg)	—	COMPLETED	2016-08-12	NCT02859259
ViiV Healthcare	Cabotegravir 30 mg	—	COMPLETED	2016-08	NCT02799264
ViiV Healthcare	BMS-663068	—	COMPLETED	2016-06-29	NCT02666001
Merck	Methadone	—	COMPLETED	2016-06-13	NCT02715700
ViiV Healthcare	Dolutegravir 50 mg tablet	—	COMPLETED	2016-06	NCT02738931
ViiV Healthcare	BMS-663068	—	COMPLETED	2016-05-05	NCT02805556
ViiV Healthcare	Dolutegravir	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]	COMPLETED	2016-05	NCT02715479
Janssen Infectious Diseases BVBA	Rilpivirine (RPV)	—	COMPLETED	2016-04-26	NCT02547870
International Partnership for Microbicides, Inc.	Dapivirine Vaginal Ring-004 and no tampons	—	COMPLETED	2016-04-16	NCT02858024
ApoPharma	Intravenous deferiprone	—	COMPLETED	2016-03	NCT02456558
ViiV Healthcare	BMS-663068	—	COMPLETED	2016-02-22	NCT02666053
ViiV Healthcare	BMS-663068	—	COMPLETED	2016-01-11	NCT02480881
Merck	Treatment A: Doravirine 100 mg film coated tablet	—	COMPLETED	2015-12-24	NCT02549040
ViiV Healthcare	BMS-663068	—	COMPLETED	2015-11-05	NCT02508064
ViiV Healthcare	ABC/DTG/3TC FDC tablet	—	COMPLETED	2015-11	NCT02539576
ViiV Healthcare	BMS-663068	—	COMPLETED	2015-10-03	NCT02467335
ViiV Healthcare	BMS-663068	—	COMPLETED	2015-09-21	NCT02480894
ViiV Healthcare	DTG 50 mg	—	COMPLETED	2015-09	NCT02373930
ViiV Healthcare	CAB	—	COMPLETED	2015-09	NCT02411435
Merck	Raltegravir 1200 mg	—	COMPLETED	2015-08-29	NCT02473367
Merck	Ulonivirine	—	COMPLETED	2015-07-16	NCT02174159
Gilead	Bictegravir	—	COMPLETED	2015-07-06	NCT02400307
Ratiopharm GmbH	Nevirapine	Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]	COMPLETED	2015-07	NCT02202005
ViiV Healthcare	Cabotegravir 30 mg current formulation	—	COMPLETED	2015-06	NCT02345707
Gilead	Bictegravir	—	COMPLETED	2015-01-23	NCT02275065
ViiV Healthcare	BMS-663068	—	COMPLETED	2015-01-12	NCT02277600
ViiV Healthcare	Ethinyl Estadiol	—	COMPLETED	2014-12	NCT02159131
Sangamo Therapeutics	—	—	COMPLETED	2014-12	NCT01044654
ViiV Healthcare	Dolutegravir Pediatric Granules	—	COMPLETED	2014-09	NCT02185300
ViiV Healthcare	BMS-955176	—	COMPLETED	2014-08-25	NCT02157467
ViiV Healthcare	BMS-663068	—	COMPLETED	2014-07-25	NCT02164045
ViiV Healthcare	BMS-663068	—	COMPLETED	2014-07-24	NCT02138084
ViiV Healthcare	BMS-955176	—	COMPLETED	2014-07-07	NCT02095886
ViiV Healthcare	GSK1265744 Reference formulation	—	COMPLETED	2014-06	NCT02059031
ViiV Healthcare	GSK1265744	—	COMPLETED	2014-06	NCT02027454
Merck	Doravirine	Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]	COMPLETED	2014-05-12	NCT02089659
ViiV Healthcare	BMS-663068	—	COMPLETED	2014-05-01	NCT02063360
GeoVax, Inc.	JS7 plasmid DNA and MVA62B vaccine	—	COMPLETED	2014-05	NCT01378156
ViiV Healthcare	DTG	—	COMPLETED	2014-05	NCT02082808
ViiV Healthcare	Metformin 500 mg q12h	—	COMPLETED	2014-05	NCT02064374
ViiV Healthcare	GSK1265744 30 mg oral	—	COMPLETED	2014-04	NCT01754116
International Partnership for Microbicides, Inc.	—	—	COMPLETED	2014-03	NCT01755754
ViiV Healthcare	DTG	—	COMPLETED	2014-01	NCT01967771
GSK	GSK2838232	—	COMPLETED	2013-11-21	NCT01802918
ViiV Healthcare	GSK1265744 Oral	—	COMPLETED	2013-11	NCT01593046
International Partnership for Microbicides, Inc.	—	—	COMPLETED	2013-10	NCT01755741
International Partnership for Microbicides, Inc.	dapivirine	—	COMPLETED	2013-10	NCT01731574
Bristol-Myers Squibb	Atazanavir	—	COMPLETED	2013-06	NCT01837719
PX'Therapeutics	EN41-FPA2 HIV vaccine	—	COMPLETED	2013-06	NCT01509144
ViiV Healthcare	Dolutegravir 50 mg	—	COMPLETED	2013-03	NCT01762995
ViiV Healthcare	GSK1265744 injectable suspension	—	COMPLETED	2012-12	NCT01756131

Novel HIV-1 Infection Drugs by Company (New molecular entities)

4 companies have an FDA-approved novel drug for HIV-1 Infection.

Merck 2 drugs

VIIV HLTHCARE 1 drug

AGOURON PHARMS 1 drug

VIRACEPT

NELFINAVIR MESYLATE

NDA 1997

Boehringer Ingelheim 1 drug

APTIVUS

TIPRANAVIR

NDA 2005

Reformulations (21 drugs) Click to expand

Reformulations are FDA-approved versions of existing molecules in new dosage forms (e.g., oral solution vs tablet, extended-release vs immediate-release). They require a new NDA but use an already-proven active ingredient.

HIV-1 Infection Drug Targets

Molecular targets of approved and investigational HIV-1 Infection drugs — 4 targets tracked.

CYP3A 4 HIV-1 protease 1 Integrase 1 Reverse Transcriptase 1

Generic Drugs (3 ANDA approved) Click to expand

Generic drugs contain the same active ingredient as the brand-name drug and are approved via ANDA (Abbreviated New Drug Application).

RILPIVIRINE HYDROCHLORIDE

LAURUS

RITONAVIR

QUAGEN

TENOFOVIR DISOPROXIL FUMARATE

MACLEODS PHARMS LTD

Related Indications

Other Infectious Disease indications

View all Infectious Disease

Drug Categories:

Novel Drugs: NDA Type 1/2 (new molecular entity) or original BLA
Reformulations: NDA Type 3/5 (new dosage form of existing molecule)
Biosimilars: BLA-approved biologics highly similar to reference products
Generics: ANDA-approved copies of small molecule drugs

View data sources and methodology