HIV-1 Infection

Infectious Diseases
48
Pipeline Programs
8
Companies
50
Clinical Trials
2 recruiting
3
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
13
3
9
1
14
8
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
788%
RNA Therapeutic
113%
+ 43 programs with unclassified modality

On Market (3)

Approved therapies currently available

U
NEVIRAPINEApproved
nevirapine
Unknown Company
oral2012
U
NEVIRAPINE TABLETS FOR ORAL SUSPENSIONApproved
nevirapine
Unknown Company
oral
GS
TYBOSTApproved
cobicistat
Gilead Sciences
Cytochrome P450 3A Inhibitor [EPC]oral2014

Competitive Landscape

8 companies ranked by most advanced pipeline stage

GS
Gilead SciencesFOSTER CITY, CA
25 programs
4
3
1
12
3
STBPhase 41 trial
TruvadaPhase 41 trial
nevirapinePhase 41 trial
B/F/TAFPhase 31 trial
B/F/TAFPhase 31 trial
+20 more programs
Active Trials
NCT01701895Completed33Est. Oct 2015
NCT04811040Completed32Est. Oct 2023
NCT02858401Completed48Est. Feb 2019
+19 more trials
Abbott
AbbottABBOTT PARK, IL
2 programs
1
nevirapinePhase 4
Surveillance of Kaletra in Korean PatientsN/A1 trial
Active Trials
NCT01083173Completed595Est. Oct 2014
AbbVie
AbbVieNORTH CHICAGO, IL
2 programs
1
DarunavirPhase 4Small Molecule
Surveillance of Kaletra in Korean PatientsN/A
M&
Merck & Co.RAHWAY, NJ
14 programs
8
1
2
2
MK-8591APhase 31 trial
Tenofovir + lamivudine + raltegravirPhase 3Small Molecule1 trial
ART IntensificationPhase 2
Pegylated Interferon alpha 2bPhase 21 trial
VorinostatPhase 1/2Small Molecule1 trial
+9 more programs
Active Trials
NCT02592174Completed220Est. Oct 2017
NCT04820933Completed26Est. Dec 2025
NCT06034938Recruiting32Est. May 2026
+14 more trials
Allergy Therapeutics
Allergy TherapeuticsUK - West Sussex
4 programs
1
1
2
NuvaringPhase 21 trial
TelmisartanPhase 2Small Molecule1 trial
mRNA-transfected autologous dendritic cellsPhase 1/2RNA Therapeutic1 trial
VRC-HIVMAB060-00-ABPhase 11 trial
Active Trials
NCT01950325CompletedEst. Aug 2015
NCT00833781CompletedEst. Dec 2013
NCT01903031CompletedEst. Oct 2016
+1 more trials
Pfizer
PfizerNEW YORK, NY
2 programs
1
ART IntensificationPhase 21 trial
RescriptorN/A1 trial
Active Trials
NCT00823966Completed3Est. Mar 2009
NCT01019551Completed29Est. Feb 2013
Stada
StadaBosnia & Herzegovina - Banja Luka
1 program
1
FZDPhase 21 trial
Active Trials
NCT01714414CompletedEst. Feb 2017
CSL Behring
CSL BehringIL - Bradley
1 program
1
Cal-1Phase 1/21 trial
Active Trials
NCT03593187Completed2Est. Jul 2020

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
Merck & Co.Doravirine
Merck & Co.Doravirine
Merck & Co.Doravirine
Merck & Co.Doravirine
Gilead SciencesSTB
Gilead Sciencesnevirapine
Gilead SciencesTruvada
Merck & Co.Doravirine
Merck & Co.MK-8591A
Gilead SciencesB/F/TAF
Gilead SciencesB/F/TAF
Gilead SciencesE/C/F/TAF
Gilead SciencesE/C/F/TAF
Gilead SciencesE/C/F/TAF
Gilead SciencesRTV

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 10,416 patients across 50 trials

Evaluation of Pharmacokinetic Drug-drug Interactions Between Hormonal Contraceptives and Doravirine-containing ART Among Women Living With HIV in South Africa

Start: Nov 2021Est. completion: Feb 2024110 patients
Phase 4Completed

Can INSTI-associated Weight Gain be Halted or Reversed With a Switch to Doravirine/Lamivudine/Tenofovir DF?

Start: Apr 2021Est. completion: Mar 2024
Phase 4Terminated

Removal of Doravirine by Hemodialysis in HIV-Infected Patients With End-stage Renal Disease (ESRD)

Start: Mar 2021Est. completion: Jun 20218 patients
Phase 4Completed

HIV Switch Trial in Experienced Patients With Multiple Class Resistance Including NNRTI Resistance

Start: Jun 2020Est. completion: Oct 2022
Phase 4Unknown

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

Start: Dec 2014Est. completion: Feb 201672 patients
Phase 4Completed

Nevirapine vs Ritonavir-boosted Lopinavir in ART Naive HIV-infected Adults in a Resource Limited Setting

Start: Dec 2008Est. completion: Dec 2011425 patients
Phase 4Completed

SONETT: Switch Study to Once Daily HIV Treatment Regimen With Truvada

Start: Sep 2004Est. completion: Jan 200750 patients
Phase 4Completed

Doravirine and Weight Gain in Antiretroviral Naive

Start: Aug 2022Est. completion: May 20230
Phase 3Withdrawn

Open-label, Follow-up of Doravirine/Islatravir (DOR/ISL 100 mg/0.75mg) for Participants With Human Immunodeficiency Virus-1 (HIV-1) Infection (MK-8591A-033)

Start: Sep 2021Est. completion: May 20292,000 patients
Phase 3Active Not Recruiting

Study to Evaluate Switching From a Regimen of Two Nucleos(t)Ide Reverse Transcriptase Inhibitors (NRTI) Plus a Third Agent to a Fixed Dose Combination (FDC) of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), in Virologically-Suppressed, HIV-1 Infected African American Participants

Start: Aug 2018Est. completion: Aug 2020496 patients
Phase 3Completed

Study to Evaluate Switching From an E/C/F/TAF Fixed-Dose Combination (FDC) Regimen or a TDF Containing Regimen to B/F/TAF FDC in Human Immunodeficiency Virus-1 (HIV-1) Infected Participants Aged ≥ 65 Years

Start: Mar 2018Est. completion: May 202086 patients
Phase 3Completed

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

Start: Apr 2016Est. completion: Sep 2017150 patients
Phase 3Completed

Study to Evaluate 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

Start: Dec 2015Est. completion: Jul 201966 patients
Phase 3Completed

Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of E/C/F/TAF Fixed Dose Combination (FDC) in HIV-1 Infected Adults on Chronic Hemodialysis

Start: Dec 2015Est. completion: Oct 201955 patients
Phase 3Completed

Study to Evaluate the Safety and Efficacy of Switching From Regimens Consisting of Boosted Atazanavir or Darunavir Plus Either Emtricitabine/Tenofovir or Abacavir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-1 Infected Adults

Start: Nov 2015Est. completion: Dec 2019578 patients
Phase 3Completed

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

Start: Nov 2015Est. completion: Jul 2021657 patients
Phase 3Completed
NCT02273765Merck & Co.Tenofovir + lamivudine + raltegravir

Raltegravir Versus Efavirenz in Naive HIV-1-infected Patients Receiving Rifampin for Active Tuberculosis

Start: Sep 2015Est. completion: Nov 2018460 patients
Phase 3Completed

Switch Study to Evaluate F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed on Regimens Containing ABC/3TC

Start: Jun 2015Est. completion: Mar 2019567 patients
Phase 3Completed

Safety and Efficacy of a Switch to Doravirine, Tenofovir, Lamivudine (MK-1439A) in Human Immunodeficiency Virus (HIV-1)-Infected Participants Virologically Suppressed on an Anti-retroviral Regimen in Combination With Two Nucleoside Reverse Transcriptase Inhibitors (MK-1439A-024)

Start: Jun 2015Est. completion: Sep 2023673 patients
Phase 3Completed

Switch Study to Evaluate the Safety and Efficacy of Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) Fixed Dose Combination (FDC) in HIV-1 Positive Adults Who Are Virologically Suppressed on Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF)

Start: Jan 2015Est. completion: Jan 2019632 patients
Phase 3Completed

Study to Evaluate Switching From a Regimen Consisting of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Fixed Dose Combination (FDC) to Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) FDC in Virologically-Suppressed, HIV-1 Infected Adults

Start: Jan 2015Est. completion: Jan 2019881 patients
Phase 3Completed

Safety and Efficacy of Doravirine (MK-1439) in Participants With Human Immunodeficiency Virus 1 (HIV-1) (MK-1439-018)

Start: Dec 2014Est. completion: Mar 2023769 patients
Phase 3Completed

Switch Study to Evaluate F/TAF in HIV-1 Positive Participants Who Are Virologically Suppressed on Regimens Containing FTC/TDF

Start: May 2014Est. completion: Mar 2019668 patients
Phase 3Completed

Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination in Adolescents and Children With Human Immunodeficiency Virus-1

Start: Sep 2016Est. completion: Nov 2026177 patients
Phase 2/3Active Not Recruiting

DOR/TDF/3TC Switch With M184V/I in People With Controlled HIV (Drive Off-Road)

Start: Feb 2024Est. completion: May 202632 patients
Phase 2Recruiting

Doravirine (DOR) in Human Immunodeficiency Virus (HIV)-Infected Children Aged 4 Weeks to <12 Years and <45 kg (MK-1439-066)

Start: Feb 2021Est. completion: Apr 203484 patients
Phase 2Recruiting

Safety and Efficacy of Doravirine, Tenofovir, Lamivudine (MK-1439A) in Participants Infected With Treatment-Naïve Human Immunodeficiency Virus (HIV) -1 With Transmitted Resistance (MK-1439A-030)

Start: Jan 2016Est. completion: Oct 202010 patients
Phase 2Completed

Safety and Efficacy of Bictegravir + Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

Start: Mar 2015Est. completion: Feb 201998 patients
Phase 2Completed

Evaluating Pharmacokinetic Interactions With Vaginal Ring Contraceptives and ART

Start: Dec 2014Est. completion: Oct 2016
Phase 2Completed

Telmisartan to Reduce AIDS-Related Fibrotic and Inflammatory Contributors (TRAFIC Study)

Start: Jan 2014Est. completion: Mar 2016
Phase 2Completed
NCT01935089Merck & Co.Pegylated Interferon alpha 2b

Pilot Peg-Interferon-a2b in Decreasing Viral DNA in HIV

Start: Aug 2013Est. completion: May 201620 patients
Phase 2Completed

A Trial to Confirm a Sustained Virological Suppression Defined as HIV-RNA <50 Copies/ml of 3 Different Doses of Fozivudine in Context to a Standard Zidovudine Based Antiretroviral Therapy Regimen

Start: Dec 2012Est. completion: Feb 2017
Phase 2Completed

Study to Evaluate Switching From a Regimen Consisting of the Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (STR) to the Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate STR

Start: Jan 2011Est. completion: Mar 201250 patients
Phase 2Completed
NCT01019551PfizerART Intensification

Therapeutic Intensification Plus Immunomodulation in HIV-infected Patients

Start: Sep 2010Est. completion: Feb 201329 patients
Phase 2Completed

Safety and Efficacy of Cobicistat-boosted Atazanavir Compared to Ritonavir-boosted Atazanavir in Combination With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

Start: May 2009Est. completion: Jan 201585 patients
Phase 2Completed

Safety of EVG+RTV Administered With Other Antiretroviral Agents for the Treatment of HIV-1 Infection

Start: Feb 2007Est. completion: Mar 2015192 patients
Phase 2Completed

A Study Evaluating the Safety of Cal-1 (LVsh5/C46) Drug Product in HIV-1 Infected Patient With High Risk Lymphoma

Start: Jan 2019Est. completion: Jul 20202 patients
Phase 1/2Completed

The Effect of Vorinostat on HIV RNA Expression in the Resting CD4+ T Cells of HIV+ Pts on Stable ART

Start: Feb 2011Est. completion: Mar 201625 patients
Phase 1/2Completed
NCT00833781Allergy TherapeuticsmRNA-transfected autologous dendritic cells

A Pilot Study of a Dendritic Cell Vaccine in HIV-1 Infected Subjects

Start: Aug 2009Est. completion: Dec 2013
Phase 1/2Completed

Doravirine Versus Integrase Inhibitors on Backbone of Emtricitabine and Tenofovir Alafenamide in HIV

Start: Mar 2024Est. completion: Dec 202526 patients
Phase 1Completed

A Study of Doravirine and Islatravir as a Single Entity or Combination Therapy and the Effect of Food in Healthy Adult Participants (MK-8591A-055)

Start: Jan 2024Est. completion: Mar 202424 patients
Phase 1Completed

Study to Evaluate the Safety and Efficacy of Teropavimab and Zinlirvimab in Combination With Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection

Start: Apr 2021Est. completion: Oct 202332 patients
Phase 1Completed

Islatravir and Methadone Pharmacokinetics (MK-8591-029)

Start: Oct 2020Est. completion: Jul 202114 patients
Phase 1Completed

Pharmacokinetics of Plasma Doravirine Once Daily Over 72 Hours Following Drug Intake Cessation in Healthy Volunteers

Start: Jun 2019Est. completion: Aug 201924 patients
Phase 1Completed

Safety, Tolerability, Pharmacokinetics, and Anti-Retroviral Activity of MK-8558 Monotherapy in Anti-Retroviral-Naïve HIV-1 Infected Participants (MK-8558-002)

Start: Apr 2019Est. completion: May 202021 patients
Phase 1Completed

Doravirine, Rifapentine and Isoniazid Interaction

Start: Apr 2019Est. completion: May 201911 patients
Phase 1Completed

MK-8583 Single Dose Study in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants (MK-8583-002)

Start: Oct 2018Est. completion: Mar 20195 patients
Phase 1Completed

Single-Dose Study of MK-4250 Monotherapy in Anti-Retroviral Therapy-Naive, Human Immunodeficiency Virus (HIV)-1 Infected Participants (MK-4250-002)

Start: Jan 2018Est. completion: Nov 201824 patients
Phase 1Completed

Activity of MK-8504 in Anti-retroviral-naïve, Human Immunodeficiency Virus 1 (HIV-1) Infected Participants (MK-8504-002)

Start: Sep 2017Est. completion: Jun 201812 patients
Phase 1Completed

A Study Evaluating the Pharmacokinetics of Doravirine (MK-1439) in Participants With Severe Renal Impairment (MK-1439-051)

Start: Jan 2016Est. completion: May 201616 patients
Phase 1Completed

Related Jobs in Infectious Diseases

Phase Legend

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

Key Insights

14 late-stage (Phase 3) programs — potential near-term approvals
2 actively recruiting trials targeting 10,416 patients
8 companies competing in this space