National Institute of Allergy and Infectious Diseases (NIAID): HIV Infections trials

The registry lists 728 HIV Infections studies with National Institute of Allergy and Infectious Diseases (NIAID) as lead sponsor. 9 are open to participants now and 104 have results posted.

Phase 1 327Phase 2 183Phase 3 57Phase 4 7No phase 195(a study in two phases counts in both)

Studies

Page 1 of 8. Open to participants first, then studies with results posted, then the rest; newest registration first within each.

• Expanding HOPE LiverRecruitingNCT07778459
• A Trial of Stratified Patient-Centered Treatment Regimens for Active TB (SPECTRA-TB)Not yet recruitingNCT07595042Phase 2
• Dasatinib for HIV-1 Reservoir ReductionRecruitingNCT07342491Phase 1
• Immunologic and Virologic Parameters During Analytical Treatment Interruption Following Combination bNAb Therapy During Suppressive ARTEnrolling by invitationNCT06908083Phase 1
• Clinical Trial to Evaluate the Safety and Immunogenicity of a Priming Regimen of 426c.Mod.Core-C4b Followed by HxB2.WT.Core-C4b Boosts, Both Adjuvanted With 3M-052 AF + Alum, in Adult Participants Without HIV and in Overall Good HealthRecruitingNCT06796686Phase 1
• Clinical Trial to Evaluate the Safety and Immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in Adult Participants Who Previously Participated in HVTN 706RecruitingNCT06665646Phase 1
• Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV RemissionRecruitingNCT02140255Phase 1/2
• Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research ParticipantsRecruitingNCT00039689
• Leukapheresis to Obtain Plasma or Lymphocytes for Studies of HIV-infected Patients, Including Long-term Non-progressorsRecruitingNCT00029445
• Clinical Trial to Evaluate the Safety and Immunogenicity of Synthetic DNAs Encoding NP-GT8 and IL-12, With or Without a TLR-agonist-Adjuvanted HIV Env Trimer 4571 Boost, in Adults Without HIVCompletedNCT05781542Phase 1Results posted
• A Clinical Trial to Evaluate the Safety and Immunogenicity of BG505 MD39.3, BG505 MD39.3 gp151, and BG505 MD39.3 gp151 CD4KO HIV Trimer mRNA Vaccines in Healthy, HIV-uninfected Adult ParticipantsActive, not recruitingNCT05217641Phase 1Results posted
• A Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of PGDM1400LS Alone and in Combination With VRC07-523LS and PGT121.414.LS in Healthy, HIV-uninfected Adult ParticipantsCompletedNCT05184452Phase 1Results posted
• Trial to Evaluate the Safety and Immunogenicity of a Modified Vaccinia Ankara (MVA)-Based Anti-Cytomegalovirus (CMV) Vaccine (Triplex®)CompletedNCT05099965Phase 2Results posted
• Evaluating the Safety and Immunogenicity of Stabilized CH505 TF chTrimer in Healthy, HIV-uninfected Adult Participants.CompletedNCT04915768Phase 1Results posted
• A Study to Evaluate the Anti-inflammatory Effects of Letermovir (Prevymis) in Adults With Human Immunodeficiency Virus (HIV)-1 and Asymptomatic Cytomegalovirus (CMV) Who Are on Suppressive Antiretroviral Therapy, Plus Its Effect on Chronic Inflammation, HIV Persistence and Other Clinical Outcomes.TerminatedNCT04840199Phase 2Results posted
• A Study to Assess the Safety and Immune Response to Env-C DNA and Protein Vaccines in KenyaCompletedNCT04826094Phase 1Results posted
• Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV Among Adolescent FemalesCompletedNCT04824131Phase 2Results posted
• Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV Among Adolescent MalesCompletedNCT04692077Phase 2Results posted
• Drug-Drug Interactions Between Rifapentine and Dolutegravir in HIV/LTBI Co-Infected IndividualsTerminatedNCT04272242Phase 2Results posted
• Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of the Monoclonal Antibody PGT121.414.LS Administered Alone and in Combination With VRC07-523LS Via Intravenous or Subcutaneous Infusions in Healthy, HIV-uninfected Adult ParticipantsCompletedNCT04212091Phase 1Results posted
• B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-BCompletedNCT04193189Phase 3Results posted
• Evaluating the Safety and Immunogenicity of HIV-1 BG505 SOSIP.664 gp140 With TLR Agonist and/or Alum Adjuvants in Healthy, HIV-uninfected AdultsCompletedNCT04177355Phase 1Results posted
• Safety and Drug Detection Study of Dapivirine Vaginal Ring and Oral TRUVADA® in Breastfeeding Mother-Infant PairsCompletedNCT04140266Phase 3Results posted
• Safety and Pharmacokinetic Study of Tenofovir Alafenamide (TAF)/Elvitegravir (EVG) Administered RectallyCompletedNCT04047420Phase 1Results posted
• Randomized, Open Label Safety Trial of Dapivirine Vaginal Ring and Oral TRUVADA® Use in PregnancyCompletedNCT03965923Phase 3Results posted
• Evaluating the Safety and Immunogenicity of an HIV-1 gp41 MPER-656 Liposome Vaccine in Healthy, HIV-uninfected Adult ParticipantsCompletedNCT03934541Phase 1Results posted
• Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Combinations of Monoclonal Antibodies PGT121, PGDM1400, 10-1074, and VRC07-523LS Administered Via Intravenous Infusion in Healthy, HIV-uninfected Adult ParticipantsCompletedNCT03928821Phase 1Results posted
• A Clinical Trial in Healthy, HIV-1-Uninfected Adult Participants to Compare the Safety, Tolerability and Immunogenicity of CH505TF gp120 Produced From Stably Transfected Cells to CH505TF gp120 Produced From Transiently Transfected CellsCompletedNCT03856996Phase 1Results posted
• Safety and Immunotherapeutic Activity of an Anti-PD-1 Antibody (Cemiplimab) in Participants With HIV-1 on Suppressive cARTTerminatedNCT03787095Phase 1/2Results posted
• Dose, Safety, Tolerability, and Immunogenicity of an HIV-1 Vaccine, VRC-HIVRGP096-00-VP, With Alum in Healthy AdultsCompletedNCT03783130Phase 1Results posted
• The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of AgeCompletedNCT03760458Phase 1/2Results posted
• Long-Acting Cabotegravir Plus VRC-HIVMAB075-00-AB (VRC07-523LS) for Viral Suppression in Adults Living With HIV-1CompletedNCT03739996Phase 2Results posted
• Evaluating the Safety and Pharmacokinetics of VRC07-523LS in the Sera and Mucosae of Healthy, HIV-Uninfected Adult ParticipantsCompletedNCT03735849Phase 1Results posted
• Dual bNAb Treatment in ChildrenCompletedNCT03707977Phase 1/2Results posted
• Pharmacokinetic and Safety Study of a 90 Day Intravaginal Ring Containing TenofovirCompletedNCT03670355Phase 1Results posted
• Phase 4 Comparative Trial of Benzathine Penicillin G for Treatment of Early Syphilis in Subjects With or Without HIV InfectionCompletedNCT03637660Phase 4Results posted
• The LATITUDE Study: Long-Acting Therapy to Improve Treatment SUccess in Daily LifECompletedNCT03635788Phase 3Results posted
• Evaluating the Safety of and Adherence to a Vaginal Matrix Ring Containing Dapivirine and Oral Emtricitabine/Tenofovir Disoproxil Fumarate in an Adolescent and Young Adult Female PopulationCompletedNCT03593655Phase 2Results posted
• HIV-1-Gag Conserved-Element DNA Vaccine (p24CE) Vaccine StudyCompletedNCT03560258Phase 1/2Results posted
• More Options for Children and Adolescents (MOCHA): Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in HIV-Infected Children and AdolescentsCompletedNCT03497676Phase 1/2Results posted
• 2-5 Intermittent Caloric Restriction in HIVTerminatedNCT03489109Not applicableResults posted
• Evaluating the Safety and Immunogenicity of Env (A,B,C,A/E)/Gag (C) DNA and gp120 (A,B,C,A/E) Protein/GLA-SE HIV Vaccines, Given Individually or Co-administered, in Healthy, HIV-1-Uninfected AdultsCompletedNCT03409276Phase 1Results posted
• Evaluating the Safety and Pharmacokinetics of PC-1005 Administered Rectally to HIV-1 Seronegative AdultsCompletedNCT03408899Phase 1Results posted
• Evaluating the Safety and Serum Concentrations of a Human Monoclonal Antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), Administered in Multiple Doses and Routes to Healthy, HIV-uninfected AdultsCompletedNCT03387150Phase 1Results posted
• Evaluating the Pharmacokinetics, Feasibility, Acceptability, and Safety of Oral Pre-Exposure Prophylaxis for HIV Prevention During Pregnancy and PostpartumCompletedNCT03386578Phase 2Results posted
• Selective Estrogen Receptor Modulators to Enhance the Efficacy of Viral Reactivation With Histone Deacetylase InhibitorsCompletedNCT03382834Phase 2Results posted
• Evaluating the Safety and Immunogenicity of an HIV Vaccine (gp145 C.6980) in Healthy, HIV-Uninfected Adults in the United StatesCompletedNCT03382418Phase 1Results posted
• A Single Dose of Pembrolizumab in HIV-Infected PeopleTerminatedNCT03367754Phase 1Results posted
• Evaluating the Pharmacokinetics, Safety, and Tolerability of Doravirine (MK-1439) and Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (MK-1439A) in HIV-1-Infected Children and AdolescentsCompletedNCT03332095Phase 1/2Results posted
• Safety and Immunogenicity of Clade C ALVAC and gp120 HIV VaccineCompletedNCT03284710Phase 1/2Results posted
• Safety and Pharmacokinetic Study of Dapivirine Gel (0.05%) Administered Rectally to HIV-1 Seronegative AdultsCompletedNCT03239483Phase 1Results posted
• Evaluating the Safety and Immunogenicity of EnvSeq-1 and CH505 M5 gp120 Envs Adjuvanted With GLA-SE in Healthy, HIV-Uninfected AdultsCompletedNCT03220724Phase 1Results posted
• Evaluating the Safety and Antiviral Activity of Monoclonal Antibody VRC01 in Infants With HIV Receiving Combination Antiretroviral TherapyCompletedNCT03208231Phase 1/2Results posted
• Safety and Immunogenicity of pDNA Vaccines Expressing HIV M Group p24^Gag Conserved Elements and/or p55^Gag, Administered With IL-12 pDNACompletedNCT03181789Phase 1Results posted
• Evaluating the Safety and Efficacy of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected WomenActive, not recruitingNCT03164564Phase 3Results posted
• Evaluating the Pharmacokinetics, Safety, and Tolerability of Delamanid in Combination With Optimized Multidrug Background Regimen (OBR) for Multidrug-Resistant Tuberculosis (MDR-TB) in Children With MDR-TB With and Without HIVCompletedNCT03141060Phase 1/2Results posted
• Evaluating the Safety and Immunogenicity of ALVAC-HIV and MF59®- or AS01B-adjuvanted Bivalent Subtype C gp120 in Healthy, HIV-uninfected Adult ParticipantsCompletedNCT03122223Phase 1/2Results posted
• Evaluating the Efficacy and Safety of Dolutegravir-Containing Versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and Their InfantsCompletedNCT03048422Phase 3Results posted
• Pivotal Phase 2b/3 ALVAC/Bivalent gp120/MF59 HIV Vaccine Prevention Safety and Efficacy Study in South AfricaCompletedNCT02968849Phase 2/3Results posted
• Evaluating the Safety and Immunogenicity of HIV Clade C DNA Vaccine and MF59- or AS01B-Adjuvanted Clade C Env Protein Vaccines in Various Combinations in Healthy, HIV-Uninfected AdultsCompletedNCT02915016Phase 1/2Results posted
• Evaluating the Immunogenicity of the AIDSVAX B/E Vaccine and the MVA/HIV62B Vaccine in Healthy, HIV-1-Uninfected Adults Who Previously Received MVA/HIV62B in DNA/MVA or MVA/MVA Regimens in HVTN 205CompletedNCT02852005Phase 1Results posted
• Evaluating the Safety, Pharmacokinetics, and Anti-Viral Activity of VRC01 and VRC01LS in the Serum and Mucosa of Healthy, HIV-Uninfected AdultsCompletedNCT02797171Phase 1Results posted
• Injectable Cabotegravir Compared to TDF/FTC For PrEP in HIV-Uninfected Men and Transgender Women Who Have Sex With MenCompletedNCT02720094Phase 2/3Results posted
• Safety and Therapeutic Efficacy of the VRC01 Antibody in Patients Who Initiated Antiretroviral Therapy During Early Acute HIV InfectionCompletedNCT02664415Phase 2Results posted
• Cardiometabolic Effects of Eplerenone in HIV InfectionTerminatedNCT02629094Phase 2Results posted
• Safety and Virologic Effect of a Human Monoclonal Antibody (VRC01) Administered Intravenously to Adults During Early Acute HIV InfectionCompletedNCT02591420Phase 1Results posted
• Integrase and Maraviroc Intensification in Neurocognitive Dysfunction (InMIND)CompletedNCT02519777Phase 4Results posted
• Evaluating the Safety and Tolerability of Ruxolitinib in Antiretroviral-Treated HIV-Infected AdultsCompletedNCT02475655Phase 2Results posted
• VRC-HIVMAB060-00-AB (VRC01) in People With Chronic HIV Infection Undergoing Analytical Treatment InterruptionCompletedNCT02471326Phase 1Results posted
• Evaluating the Safety, Pharmacokinetics, and Antiviral Activity of a Human Monoclonal Antibody (VRC01) in HIV-Infected Adults Undergoing a Brief Treatment InterruptionCompletedNCT02463227Phase 1Results posted
• Evaluating the Safety, Tolerability, and Effect of a Human Monoclonal Antibody (VRC01) on Markers of HIV Persistence in HIV-Infected Adults Receiving Antiretroviral Therapy (ART)CompletedNCT02411539Phase 1Results posted
• A Safety and Immune Response Study of 2 Experimental HIV VaccinesCompletedNCT02404311Phase 1/2Results posted
• Evaluating the Safety and Pharmacokinetics of VRC01, VRC01LS, and VRC07-523LS, Potent Anti-HIV Neutralizing Monoclonal Antibodies, in HIV-1-Exposed InfantsCompletedNCT02256631Phase 1Results posted
• Acceptability, Safety, and Use of Daily Truvada Pre-Exposure Prophylaxis in AdolescentsCompletedNCT02213328Phase 2Results posted
• Evaluating the Safety, Tolerability, and Pharmacokinetics of an Investigational, Injectable HIV Medicine (GSK1265744) in HIV-Uninfected AdultsCompletedNCT02178800Phase 2Results posted
• Elite Controller and ART-treated HIV+ Statin Versus ASA Treatment Intervention StudyCompletedNCT02081638Phase 2Results posted
• Safety and Effectiveness of Low-Dose Methotrexate for Reducing Inflammation in HIV-Infected Adults on ARV MedicationsCompletedNCT01949116Phase 2Results posted
• Evaluating the Safety and Efficacy of Romidepsin in Combination With Antiretroviral Therapy in HIV-Infected Adults With Suppressed Viral LoadCompletedNCT01933594Phase 1/2Results posted
• Evaluating the Safety and Pharmacokinetics of Raltegravir in InfantsCompletedNCT01828073Results posted
• Assessment of Pre-Exposure Prophylaxis (PrEP) Administered at Sexually Transmitted Disease (STD) ClinicsCompletedNCT01632995Not applicableResults posted
• Evaluating the Safety and Tolerability of Antiretroviral Drug Regimens Used as Pre-Exposure Prophylaxis to Prevent HIV Infection in At-Risk Men Who Have Sex With Men and in At-Risk WomenCompletedNCT01505114Phase 2Results posted
• Evaluating the Safety and Tolerability of Etravirine in HIV-1 Infected Infants and ChildrenCompletedNCT01504841Phase 1/2Results posted
• Safety of and Immune Response to Dolutegravir in HIV-1 Infected Infants, Children, and AdolescentsCompletedNCT01302847Phase 1/2Results posted
• Evaluating Strategies to Reduce Mother-to-Child Transmission of HIV Infection in Resource-Limited CountriesCompletedNCT01061151Phase 3Results posted
• Safety of and Immune Response to an H1N1 Influenza Virus Vaccine in HIV Infected Children and YouthCompletedNCT00992836Phase 2Results posted
• Safety and Effectiveness of Alendronate for Bone Mineral Density in HIV-infected Children and AdolescentsCompletedNCT00921557Phase 2Results posted
• Safety and Effectiveness of HIV-1 DNA Plasmid Vaccine and HIV-1 Recombinant Adenoviral Vector Vaccine in HIV-Uninfected, Circumcised Men and Male-to-Female (MTF) Transgender Persons Who Have Sex With MenTerminatedNCT00865566Phase 2Results posted
• Combination Pain Therapy in HIV NeuropathyTerminatedNCT00863057Phase 2Results posted
• Safety and Immune Response to Vicriviroc in Combination Regimens in HIV-Infected ART Experienced Children and AdolescentsCompletedNCT00766597Phase 1/2Results posted
• Safety and Effectiveness of TFV 1% Gel, TDF Tablets, and FTC/TDF Tablets in Preventing HIV in WomenCompletedNCT00705679Phase 2Results posted
• HIV Screening in the Emergency Department SettingCompletedNCT00667186Not applicableResults posted
• Adherence and Acceptability to and Blood Levels of Tenofovir Gel and Tablets in HIV Uninfected WomenCompletedNCT00592124Phase 2Results posted
• Optimizing Treatment for Treatment-Experienced, HIV-Infected PeopleCompletedNCT00537394Phase 3Results posted
• Effect of Addition of Raltegravir (MK-0518) to PI- or NNRTI-Based ART Regimens in HIV Infected Subjects With Undetectable Viral LoadCompletedNCT00515827Phase 2Results posted
• Safety and Pharmacokinetics (PK) of Raltegravir in HIV (Human Immunodeficiency Virus)-Infected Children and AdolescentsCompletedNCT00485264Phase 1/2Results posted
• Emtricitabine/Tenofovir Disoproxil Fumarate for HIV Prevention in MenCompletedNCT00458393Phase 3Results posted
• Pioglitazone to Treat Fatty Liver in People With HIV InfectionCompletedNCT00441272Phase 2Results posted
• Metabolic Effects of Non-Thymidine Analogue Anti-HIV MedicationsCompletedNCT00433992Results posted
• Effectiveness of Palifermin in Increasing CD4 Counts in Treatment-Experienced HIV Infected AdultsCompletedNCT00376935Phase 2Results posted
• Trizivir Vs. Kaletra and Combivir for the Prevention of Mother-to-Child Transmission of HIVCompletedNCT00270296Phase 2Results posted