Active, not recruitingObservationalNCT00031408 ↗Plan for Obtaining Informed Consent to Use Stored Human Biological Materials (HBM) for Currently Unspecified AnalysesRoy M GulickPIDatesFeb 2002 – Dec 2027 (est.)
Active, not recruitingInterventional · Phase 1NCT04340596 ↗A Phase I Clinical Trial of the Safety, Tolerability, and Efficacy of IL-15 Superagonist (N-803) With and Without Combination Broadly Neutralizing Antibodies to Induce HIV-1 Control During Analytic Treatment InterruptionMarshall J. GlesbyPIInterventionBiological: N-803 (IL-15 Superagonist) · Biological: VRC07-523LS · Biological: 10-1074DatesMay 2021 – May 2026SponsorNational Institute of Allergy & Infectious DiseasesHIV Infection
RecruitingInterventional · Not applicableNCT04949464 ↗Impact of Behavior Modification Interventions and Lung Cancer Screening on Smoking Cessation in People Living With HIV: A Feasibility StudyGrant EllsworthPIInterventionProcedure: Computed Tomography · Behavioral: Smoking Cessation InterventionDatesMar 2023 – Dec 2026 (est.)SponsorAIDS Malignancy ConsortiumHIV InfectionTobacco-Related Carcinoma
Active, not recruitingInterventional · Not applicableNCT06002126 ↗Optimization of Cervical Cancer Screening Among Women Living With HIV in Latin American CountriesGrant EllsworthPIInterventionDiagnostic test: Xpert HPV · Diagnostic test: QIAsure Methylation TestDatesAug 2023 – Jul 2025· Results postedSponsorWeill Medical College of Cornell UniversityCervix CancerHPV InfectionCervical High Grade Squamous Intraepithelial Lesion+1 more
Active, not recruitingInterventional · Phase 3NCT06694805 ↗A Phase 3b, Open Label, Randomized, standard-of Care Control Arm, Multicenter, Superiority Study Evaluating the Efficacy, Safety, and Tolerability of Injectable CAB LA + RPV LA in Viremic Participants Living With HIV-1 (CROWN)Kristen MarksPIInterventionDrug: CAB LA + RPV LA · Drug: Oral ARTDatesDec 2024 – Aug 2026SponsorVIIV HealthcareHIV Infections
RecruitingInterventional · Phase 4NCT06856174 ↗Menopausal Hormone Therapy for Women Living With HIV (HoT)Carrie JohnstonPIInterventionDrug: Transdermal estradiol gel · Drug: Micronized Progesterone · Drug: Placebo for estradiol gel · Drug: Placebo for micronized progesteroneDatesApr 2026 – Sep 2027 (est.)SponsorNational Institute of Allergy & Infectious DiseasesHIV InfectionMenopause
CompletedInterventional · Phase 4NCT02519777 ↗A Randomized, Double-Blinded, Placebo-Controlled Trial Comparing Antiretroviral Intensification With Maraviroc and Dolutegravir With No Intensification or Intensification With Dolutegravir Alone for the Treatment of Cognitive Impairment in HIVMarshall J. GlesbyPIInterventionDrug: Placebo for maraviroc (MVC) · Drug: Placebo for dolutegravir (DTG) · Drug: Dolutegravir (DTG) · Drug: Maraviroc (MVC)DatesApr 2016 – Dec 2019· Results postedSponsorNational Institute of Allergy & Infectious DiseasesHIV Infections
CompletedInterventional · Phase 3NCT03635788 ↗A Phase III Study to Evaluate Long-Acting Antiretroviral Therapy in Non-Adherent HIV-Infected IndividualsMarshall J. GlesbyPIInterventionDrug: Standard of Care (SOC) Oral ART · Drug: Oral RPV · Drug: Oral CAB · Drug: RPV-LA Loading Dose · Drug: CAB-LA Loading Dose · Drug: RPV-LA Maintenance Dose · Drug: CAB-LA Maintenance DoseDatesMar 2019 – Feb 2024· Results postedSponsorNational Institute of Allergy & Infectious DiseasesHIV Infections
CompletedInterventional · Phase 2NCT03739996 ↗A Study of Long-Acting Cabotegravir Plus VRC-HIVMAB075-00-AB (VRC07-523LS) to Maintain Viral Suppression in Adults Living With HIV-1Marshall J. GlesbyPIInterventionDrug: Oral Cabotegravir (CAB) · Drug: Nucleoside Reverse Transcriptase Inhibitors (NRTIs) · Drug: Long-Acting Injectable Cabotegravir (CAB LA) · Biological: VRC07-523LS · Drug: Standard of Care (SOC) ARTDatesDec 2019 – Apr 2024· Results postedSponsorNational Institute of Allergy & Infectious DiseasesHIV Infections
CompletedInterventional · Phase 2NCT03819114 ↗An Open-Label, Phase II Pharmacokinetic Study to Evaluate Double-Dose Levonorgestrel Emergency Contraception in Combination With Efavirenz-Based Antiretroviral Therapy or Rifampicin-Containing Anti-Tuberculosis TherapyMarshall J. GlesbyPIInterventionDrug: Levonorgestrel (LNG)DatesMay 2019 – Nov 2020· Results postedSponsorAIDS Clinical Trial GroupHIV InfectionsTuberculosis
CompletedInterventional · Phase 2NCT04042740 ↗Glecaprevir/Pibrentasvir Fixed-dose Combination Treatment for Acute Hepatitis C Virus Infection (PURGE-C)Kristen MarksPIInterventionDrug: Glecaprevir/Pibrentasvir (G/P)DatesNov 2019 – May 2023· Results postedSponsorNational Institute of Allergy & Infectious DiseasesHepatitis C InfectionHIV Infection
CompletedInterventional · Phase 3NCT04193189 ↗B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-BKristen MarksPIInterventionBiological: HEPLISAV-B · Biological: ENGERIX-BDatesDec 2020 – Aug 2024· Results postedSponsorNational Institute of Allergy & Infectious DiseasesHIV InfectionHepatitis B
CompletedInterventional · Phase 4NCT04265950 ↗Multicenter, Randomized, Open-Label Trial in Children and Adolescents to Establish Optimal Number of Doses for HPV Vaccination in Children and Adolescents Living With HIVJean W. PapePIInterventionBiological: Recombinant Human Papillomavirus Nonavalent VaccineDatesMar 2022 – May 2026SponsorFred Hutchinson Cancer CenterHIV Infection
TerminatedInterventional · Phase 2NCT04272242 ↗Drug-Drug Interactions Between Rifapentine and Dolutegravir in HIV/LTBI Co-Infected IndividualsJean W. PapePIInterventionDrug: Dolutegravir (DTG) · Drug: Isoniazid (INH) · Drug: Rifapentine (RPT) · Drug: Antiretroviral Therapy (ART) · Dietary supplement: Pyridoxine (Vitamin B6)DatesFeb 2021 – Dec 2021· Results postedSponsorNational Institute of Allergy & Infectious DiseasesHIV InfectionLTBI
CompletedInterventional · Phase 4NCT04530630 ↗The Efficacy, Safety, and Tolerability of Switching to a Bictegravir (BIC)/Emtricitabine(FTC)/Tenofovir Alafenamide (TAF) Regimen in Virally Suppressed Human Immunodeficiency Viruses (HIV)-Positive Patients Post-Renal TransplantCatherine Butkus SmallPIInterventionDrug: BIC/F/TAF 50Mg-200Mg-25Mg TabletDatesNov 2020 – Aug 2024· Results postedSponsorWeill Medical College of Cornell UniversityHIV InfectionsRenal Transplant Rejection
CompletedInterventional · Phase 4NCT04636437 ↗Doravirine for Obese Persons on Integrase Inhibitors and Tenofovir Alafenamide (The Do IT Study)Roy M GulickPIInterventionDrug: Doravirine 100 Mg · Drug: Integrase strand transfer inhibitors · Drug: Tenofovir alafenamide/emtricitabine · Drug: tenofovir disproxil fumarate/emtricitabineDatesJul 2021 – Oct 2024· Results postedSponsorNational Institute of Allergy & Infectious DiseasesHIV Infections
TerminatedInterventional · Phase 2NCT04840199 ↗Randomized, Controlled Trial to Evaluate the Anti-inflammatory Efficacy of Letermovir (Prevymis) in Adults With Human Immunodeficiency Virus (HIV)-1 and Asymptomatic Cytomegalovirus (CMV) Who Are on Suppressive ART and Its Effect on Chronic Inflammation, HIV Persistence, and Other Clinical OutcomesKristen MarksPIInterventionDrug: Letermovir Oral TabletDatesApr 2022 – Nov 2023· Results postedSponsorNational Institute of Allergy & Infectious DiseasesHIV InfectionsCytomegalovirusCMV
CompletedInterventional · Phase 2NCT05551273 ↗Safety, Tolerability, and Impact of Oral TLR8 Agonist Selgantolimod on HBsAg in Participants With Both Chronic Hepatitis B and HIVKristen MarksPIInterventionDrug: Selgantolimod · Drug: PlaceboDatesMay 2023 – Oct 2025SponsorNational Institute of Allergy & Infectious DiseasesHepatitis BHIV Infections
TerminatedObservationalNCT06045923 ↗Virologic and Immunologic Characteristics of Severe Mpox in Persons With Advanced HIVMarshall J. GlesbyPIDatesMar 2023 – Jan 2026SponsorCenters for Disease Control & PreventionMonkeypoxHIV InfectionsAIDS