Peg-Interferon Alpha 2b Combined With Two Intravenous Broadly HIV-1 Neutralizing Antibodies 3BNC117 and 10-1074 (BEAT-2)
NCT ID: NCT03588715
Last Updated: 2021-06-25
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
UNKNOWN
Clinical Phase
PHASE1
Total Enrollment
15 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-06-18
Study Completion Date
2022-10-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This study will evaluate the safety, tolerability and innate immune mechanisms activation following administration of the combination of Pegylated Interferon alpha 2b (peg-IFN-α2b) with two broadly neutralizing antibodies (3BNC117 and 10-1074) in the setting of well-controlled HIV infection with antiretroviral treatment and a monitored analytical treatment interruption. The current proposal builds on previous experience using interferon alpha, 3BNC117 and 10-1074 alone in separate clinical trials that included a closely monitored analytical treatment interruption. The hypothesis is that the joint administration of peg-IFN-α2b with 3BNC117 and 10-1074 will be more effective than either intervention separately in suppressing HIV viremia during 8 weeks of analytical treatment interruption (Step 4) and reducing integrated HIV DNA in blood and tissue when measured during an analytical treatment interruption in patients with well-controlled HIV infection.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study Evaluating AL-3778 in Combination With Peginterferon Alpha-2a in Chronic Hepatitis B Subjects
NCT03125213
Hepatitis B, Chronic
WITHDRAWN
PHASE2
Pilot Peg-Interferon-a2b in Decreasing Viral DNA in HIV
NCT01935089
HIV-1 Infection
COMPLETED
PHASE2
Augmenting Response to Entecavir With Peginterferon a-2a for the Treatment of HBeAg-positive Chronic Hepatitis B
NCT00877760
Chronic Hepatitis B
COMPLETED
PHASE4
Efficacy and Safety of PegIFN +/- FTC / TDF to Treat Chronic Hepatitis B in HIV-Coinfected Patients
NCT00221286
Chronic Hepatitis B
HIV Infections
TERMINATED
PHASE3
Peg-interferon for Inactive Chronic Hepatitis B Carriers
NCT02992704
Chronic Hepatitis, B Virus
Carrier of Viral Hepatitis Type B
COMPLETED
PHASE2/PHASE3
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The proposed study will evaluate the safety, tolerability and innate immune mechanisms activation following administration of the combination of Pegylated Interferon alpha 2b (peg-IFN-α2b) with two broadly neutralizing antibodies (3BNC117 and 10-1074) in the setting of well controlled HIV infection with antiretroviral treatment and a monitored analytical treatment interruption. This proposal builds on previous experience using interferon alpha, 3BNC117 and 10-1074 alone in separate clinical trials that included a closely monitored analytical treatment interruption. The hypothesis is that the joint administration of peg-IFN-α2b with 3BNC117 and 10-1074 will be more effective than either intervention separately in suppressing HIV viremia during 8 weeks of analytical treatment interruption (Step 4) and reducing integrated HIV DNA in blood and tissue when measured during an analytical treatment interruption in participants with well-controlled HIV infection. A review of the conceptual framework for the strategy to be tested includes:
* Why peg-IFN-α2? The therapeutic effects of peg-IFN-α2 yield two essential outcomes that are the fundamental objectives of HIV curative strategies: control viral replication in the absence of ART and reduce the levels of integrated HIV DNA in CD4+ T-cells. To date, peg-IFN-α is the only intervention that has been shown to maintain viral suppression to levels \<50 copies/mL in the absence of ART in chronic infection. Preliminary data supports that correlates of anti-HIV reductions are centered on activation of NK responses.
* Why bNAbs + peg-IFN-α2b? The addition of bNAbs may act independently to control virus replication or decrease fitness thereby increasing the potential for a larger antiviral effect after IFN by enhance NK-mediated clearance via a reduced viral levels and the complementarity of bNAbs in enhancing mechanisms of antibody-mediated cytotoxicity against infected cells by binding to virus emerging from or viral proteins expressed on activated latent cells.
* Why combined bNAbs? In vivo, multiple bNAbs targeting different epitopes provide better neutralization and antigen recognition than single bNAbs, which suggests that adoptive transfer of multiple bNAbs may lead to superior viral control. Although bNAbs may have neutralization effects that are of greater clinical impact than ADCC, it is possible that antigen targeting through multiple bNAbs may also enhance NK-mediated cytotoxicity more than a single bNAb. The administration of broadly neutralizing antibodies alone in the setting of an analytical treatment interruption delays the return of viremia in a fraction of the participants.
* Why test an ATI of immunotherapy? To date, peg-IFN-α2 administered prior to an ATI or ART and subsequently maintained throughout the ATI period has maintained viral suppression. An effective curative strategy requires that all interventions be discontinued.
* Why peg-IFN-α2? The therapeutic effects of peg-IFN-α2 yield two essential outcomes that are the fundamental objectives of HIV curative strategies: control viral replication in the absence of ART and reduce the levels of integrated HIV DNA in CD4+ T-cells. To date, peg-IFN-α is the only intervention that has been shown to maintain viral suppression to levels \<50 copies/mL in the absence of ART in chronic infection. Preliminary data supports that correlates of anti-HIV reductions are centered on activation of NK responses.
* Why bNAbs + peg-IFN-α2b? The addition of bNAbs may act independently to control virus replication or decrease fitness thereby increasing the potential for a larger antiviral effect after IFN by enhance NK-mediated clearance via a reduced viral levels and the complementarity of bNAbs in enhancing mechanisms of antibody-mediated cytotoxicity against infected cells by binding to virus emerging from or viral proteins expressed on activated latent cells.
* Why combined bNAbs? In vivo, multiple bNAbs targeting different epitopes provide better neutralization and antigen recognition than single bNAbs, which suggests that adoptive transfer of multiple bNAbs may lead to superior viral control. Although bNAbs may have neutralization effects that are of greater clinical impact than ADCC, it is possible that antigen targeting through multiple bNAbs may also enhance NK-mediated cytotoxicity more than a single bNAb. The administration of broadly neutralizing antibodies alone in the setting of an analytical treatment interruption delays the return of viremia in a fraction of the participants.
* Why test an ATI of immunotherapy? To date, peg-IFN-α2 administered prior to an ATI or ART and subsequently maintained throughout the ATI period has maintained viral suppression. An effective curative strategy requires that all interventions be discontinued.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
HIV
HIV/AIDS
HIV-1 Infection
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
NON_RANDOMIZED
Intervention Model
PARALLEL
The study will evaluate the impact of the combination of 3BNC117 and 10-1074 with or without antiretroviral therapy in virological rebound during an ATI and effects on the HIV reservoir.
This will be a pilot phase I study to evaluate the safety, tolerability, pharmacokinetics (PK), and antiviral activity of a combination of Pegylated Interferon alpha 2b with the two broadly neutralizing antibodies (3BNC117 and 10-1074) in 14 (all recruited first) individuals or the combination the broadly neutralizing antibodies alone in 7 (only 1 was able to be recruited due to COVID delays and drug availability) HIV-1 infected individuals, undergoing a brief analytical treatment interruption (ATI).
This will be a pilot phase I study to evaluate the safety, tolerability, pharmacokinetics (PK), and antiviral activity of a combination of Pegylated Interferon alpha 2b with the two broadly neutralizing antibodies (3BNC117 and 10-1074) in 14 (all recruited first) individuals or the combination the broadly neutralizing antibodies alone in 7 (only 1 was able to be recruited due to COVID delays and drug availability) HIV-1 infected individuals, undergoing a brief analytical treatment interruption (ATI).
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Pegylated Interferon alpha 2b + bNAbs
Pegylated Interferon alpha 2b (peg-IFN-α2b) + bNAbs (3BNC117 + 10-1074)
Group Type
EXPERIMENTAL
Pegylated Interferon alpha 2b (peg-IFN-α2b)
Intervention Type
DRUG
Pegylated Interferon alpha 2b (peg-IFN-α2b) will be administered weekly via subcutaneous route.
3BNC117 + 10-1074
Intervention Type
DRUG
Broadly Neutralizing Antibodies - Sequential, separate IV infusions of 3NBC117 + 10-1074.
bNAb only
bNAb (3BNC117 + 10-10-74) only
Group Type
EXPERIMENTAL
3BNC117 + 10-1074
Intervention Type
DRUG
Broadly Neutralizing Antibodies - Sequential, separate IV infusions of 3NBC117 + 10-1074.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pegylated Interferon alpha 2b (peg-IFN-α2b)
Pegylated Interferon alpha 2b (peg-IFN-α2b) will be administered weekly via subcutaneous route.
Intervention Type
DRUG
3BNC117 + 10-1074
Broadly Neutralizing Antibodies - Sequential, separate IV infusions of 3NBC117 + 10-1074.
Intervention Type
DRUG
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Pegintron
Broadly Neutralizing Antibodies
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA VL
* Ability and willingness of participant to provide informed consent
* Men and women aged ≥18 years
* Clinically stable on their first or second ART regimen that includes a boosted protease inhibitor or an integrase inhibitor. The current regimen should be stable for 4 weeks at the time of entry. Changes while the patient HIV viral load is undetectable does not count toward the number of ART regimens used, (for example an individual switching from an NNRTI-based regimen to an integrase inhibitor based regimen while the HIV viral load is undetectable will still be in their first regimen)
* HIV-1 RNA that is \<50 copies/mL using a FDA-approved assay performed by any laboratory that has a CLIA certification or its equivalent within 56 days prior to study entry
NOTE: HIV-1 RNA must be measured at least once in the 24 weeks prior to entry and at least 3 days before the screening measure. Single determinations that are between ≥50 and \<400 copies/mL (i.e., blips) are allowed as long as the preceding and subsequent determinations are \<50 copies/mL. The screening value may serve as the subsequent determination \<50 copies/mL following a blip
* Screening CD4+ T-cell count ≥450 cells/μL within 45 days prior to study entry
* Willingness to have blood samples collected and used for study-related research purposes
* The following laboratory values obtained within 45 days prior to enrollment:
* Absolute neutrophil count (ANC) ≥1000 cells/mm3
* Hemoglobin ≥12.0 g/dL for men and ≥11 g/dL for women
* Platelet count 100,000/mm3
* Creatinine clearance ≥60 mL/min estimated by the Cockcroft-Gault equation
* Alanine aminotransferase (ALT) ≤2.5 x ULN
* Pancreatic amylase ≤ 1.5 ULN and lipase ≤ 1.5 ULN and triglycerides ≤ 750 mg/dl
* total bilirubin ≤ 1.5x ULN, (if not receiving atazanavir) OR direct bilirubin ≤ 1 mg/dl (if receiving atazanavir)
* For females of reproductive potential (i.e., women who have not been post-menopausal for at least 24 consecutive months, who have had menses within the preceding 24 months, or women who have not undergone surgical sterilization, specifically hysterectomy and/or bilateral oophorectomy or bilateral salpingectomy), negative urine pregnancy test (with a sensitivity of 15-25 mIU/mL) within 48 hours prior to screening and entry.
ADDITIONAL REQUIREMENTS BIOLOGICAL FEMALES ARE NOTED IN CLINICAL PROTOCOL.
-Female partners of reproductive potential of male study participants on study drug would be educated that:
At least two of the following contraceptives MUST be used appropriately by female partners of reproductive potential of male study participants and/or their male partners with one method being highly effective and the other method being either highly effective or less effective as listed below:
Highly Effective Methods of Contraception
* Male condoms with spermicide
* Hormone-based contraceptives including combined oral contraceptive pills, vaginal ring, injectables, implants, and intrauterine devices (IUDs) such as Mirena by male participant's female partner of reproductive potential.
* Nonhormonal IUDs, such as ParaGard
* Tubal ligation
* Complete Abstinence\*
* \*Complete abstinence as defined as complete avoidance of heterosexual intercourse. Participants who choose complete abstinence are not required to use a second method of contraception. Acceptable alternate methods of highly effective contraception must be discussed in the event that the participant chooses to forego complete abstinence.
NOTE: Female partners of male participants participating in the study may use hormone based contraceptives as one of the acceptable methods of contraception since they will not be receiving study drug.
* Negative HBsAg result obtained within 6 months prior to study entry.
* HCV antibody negative result within 6 months prior to entry, or if the HCV antibody result is positive, a negative HCV RNA obtained within 6 months prior to study entry. Treated and cured HCV infected participants are allowed.
* Adequate venous access in at least one arm
* Body weight ≥ 125 and ≤ 300 lbs
* A non-clinically significant electrocardiogram (EKG, see section 7.2) for:
1. men \>45 years or women \> 55 years of age
2. younger subjects of either sex with two risk factors for coronary artery disease \[smoking, hypertension (BP \>140/90 or on antihypertensive medications), low HDL (\<40 mg/dl), family history of premature CHD (\<55 yrs males/\<65 females
3. subjects with a Framingham score \> 15% (men) or 10% (women)
* Ability and willingness of participant to provide informed consent
* Men and women aged ≥18 years
* Clinically stable on their first or second ART regimen that includes a boosted protease inhibitor or an integrase inhibitor. The current regimen should be stable for 4 weeks at the time of entry. Changes while the patient HIV viral load is undetectable does not count toward the number of ART regimens used, (for example an individual switching from an NNRTI-based regimen to an integrase inhibitor based regimen while the HIV viral load is undetectable will still be in their first regimen)
* HIV-1 RNA that is \<50 copies/mL using a FDA-approved assay performed by any laboratory that has a CLIA certification or its equivalent within 56 days prior to study entry
NOTE: HIV-1 RNA must be measured at least once in the 24 weeks prior to entry and at least 3 days before the screening measure. Single determinations that are between ≥50 and \<400 copies/mL (i.e., blips) are allowed as long as the preceding and subsequent determinations are \<50 copies/mL. The screening value may serve as the subsequent determination \<50 copies/mL following a blip
* Screening CD4+ T-cell count ≥450 cells/μL within 45 days prior to study entry
* Willingness to have blood samples collected and used for study-related research purposes
* The following laboratory values obtained within 45 days prior to enrollment:
* Absolute neutrophil count (ANC) ≥1000 cells/mm3
* Hemoglobin ≥12.0 g/dL for men and ≥11 g/dL for women
* Platelet count 100,000/mm3
* Creatinine clearance ≥60 mL/min estimated by the Cockcroft-Gault equation
* Alanine aminotransferase (ALT) ≤2.5 x ULN
* Pancreatic amylase ≤ 1.5 ULN and lipase ≤ 1.5 ULN and triglycerides ≤ 750 mg/dl
* total bilirubin ≤ 1.5x ULN, (if not receiving atazanavir) OR direct bilirubin ≤ 1 mg/dl (if receiving atazanavir)
* For females of reproductive potential (i.e., women who have not been post-menopausal for at least 24 consecutive months, who have had menses within the preceding 24 months, or women who have not undergone surgical sterilization, specifically hysterectomy and/or bilateral oophorectomy or bilateral salpingectomy), negative urine pregnancy test (with a sensitivity of 15-25 mIU/mL) within 48 hours prior to screening and entry.
ADDITIONAL REQUIREMENTS BIOLOGICAL FEMALES ARE NOTED IN CLINICAL PROTOCOL.
-Female partners of reproductive potential of male study participants on study drug would be educated that:
At least two of the following contraceptives MUST be used appropriately by female partners of reproductive potential of male study participants and/or their male partners with one method being highly effective and the other method being either highly effective or less effective as listed below:
Highly Effective Methods of Contraception
* Male condoms with spermicide
* Hormone-based contraceptives including combined oral contraceptive pills, vaginal ring, injectables, implants, and intrauterine devices (IUDs) such as Mirena by male participant's female partner of reproductive potential.
* Nonhormonal IUDs, such as ParaGard
* Tubal ligation
* Complete Abstinence\*
* \*Complete abstinence as defined as complete avoidance of heterosexual intercourse. Participants who choose complete abstinence are not required to use a second method of contraception. Acceptable alternate methods of highly effective contraception must be discussed in the event that the participant chooses to forego complete abstinence.
NOTE: Female partners of male participants participating in the study may use hormone based contraceptives as one of the acceptable methods of contraception since they will not be receiving study drug.
* Negative HBsAg result obtained within 6 months prior to study entry.
* HCV antibody negative result within 6 months prior to entry, or if the HCV antibody result is positive, a negative HCV RNA obtained within 6 months prior to study entry. Treated and cured HCV infected participants are allowed.
* Adequate venous access in at least one arm
* Body weight ≥ 125 and ≤ 300 lbs
* A non-clinically significant electrocardiogram (EKG, see section 7.2) for:
1. men \>45 years or women \> 55 years of age
2. younger subjects of either sex with two risk factors for coronary artery disease \[smoking, hypertension (BP \>140/90 or on antihypertensive medications), low HDL (\<40 mg/dl), family history of premature CHD (\<55 yrs males/\<65 females
3. subjects with a Framingham score \> 15% (men) or 10% (women)
Exclusion Criteria
* Susceptibility to bNAb 10-1074 based on IC90 greater than 2.0 µg/mL or susceptibility to bNAb 3BNC117 based on IC90 greater than 1.5 µg/mL using the Monogram Phenosense Assay on sample obtained on ART in absence of a subsequent documentation of a HIV viral load of greater than 1,000 copies on a collection date after that of the bNAb sensitivity sample.
* Previous receipt of humanized or human monoclonal antibody whether licensed or investigational
* Weight \>300 lbs or \<125 lbs
* History of an AIDS-defining illness
* Ongoing AIDS-related opportunistic infection (including oral thrush)
* History of a severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis in the 2 years prior to enrollment
* Currently pregnant, breastfeeding, or planning pregnancy
* Receipt of other investigational study agent within 30 days prior to enrollment
* Current or prior medications:
* Confirmed clinical history of developing resistance to ART regimens that resulted in treatment changes
* Receiving didanosine as part of the participant's ART regimen at the time of screening
* Ongoing treatment with Isoniazid, Pyrazinamide, Rifabutin, Rifampicin, Ganciclovir, Valgancyclovir, Oxymetholone, Thalidomide or Theophylline.
* Ongoing treatment with anticoagulants
* Use of any investigational drug within 30 days prior to screening
* History or current use of immunomodulatory therapy for over 2 weeks during the 6 months prior to enrollment, including, but not limited to:
* IFN-α or γ (recombinant or pegylated)
* Systemic corticosteroids (inhaled steroids allowed at the discretion of the Investigator)
* Systemic cancer chemotherapy/irradiation
* cyclosporin; tacrolimus (FK-506)
* OKT-3
* Any Interleukin, including IL-2
* Cyclophosphamide
* Methotrexate
* IVIG (gamma globulin)
* G/M-CSF
* Hydroxyurea
* Thalidomide
* Pentoxifylline
* Thymopentin, thymosin
* Dithiocarbonate
* Polyribonucleoside.
* History of adverse or allergic reactions to any type-1 interferon (e.g. IFN-α2a, IFN-α2b, IFN-β)
* Any other chronic or clinically significant medical condition that in the opinion of investigator would jeopardize the safety or rights of the volunteer, including, clinically significant forms of:
* Drug or alcohol abuse
* Severe asthma
* Uncontrolled hypertension
* Type I diabetes mellitus, or type II diabetes mellitus that is not controlled with oral agents and/or insulin (i.e.: subjects with a history of diabetes mellitus and HA1C of \> 9 in the last 3 months or at screening)
* Psychiatric disorders, including severe depression and/or suicidal ideation
* Heart disease
* Cancer or hematologic malignancies
* Prior diagnosis of multiple sclerosis or other neurodegenerative disorders
* Liver cirrhosis or hepatic decompensation
* Chronic HCV infection (HCV viremia), or HBV Ag positive and/ or HBV viremia (Notice: subjects with prior HCV infection with a documented sustained virologic response at 24 weeks post treatment prior to screening are eligible for enrollment.
* Major organ transplantation with an existing functional graft
* Active autoimmune diseases, including autoimmune hepatitis
* History of retinopathy or clinically significant ophthalmologic disease
* Opportunistic infections or other active infectious diseases
* Other conditions, such as active drug/alcohol abuse or dependence, that in the opinion of the Investigator would interfere with study compliance.
* Initiation of treatment during acute infection
* Previous receipt of humanized or human monoclonal antibody whether licensed or investigational
* Weight \>300 lbs or \<125 lbs
* History of an AIDS-defining illness
* Ongoing AIDS-related opportunistic infection (including oral thrush)
* History of a severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis in the 2 years prior to enrollment
* Currently pregnant, breastfeeding, or planning pregnancy
* Receipt of other investigational study agent within 30 days prior to enrollment
* Current or prior medications:
* Confirmed clinical history of developing resistance to ART regimens that resulted in treatment changes
* Receiving didanosine as part of the participant's ART regimen at the time of screening
* Ongoing treatment with Isoniazid, Pyrazinamide, Rifabutin, Rifampicin, Ganciclovir, Valgancyclovir, Oxymetholone, Thalidomide or Theophylline.
* Ongoing treatment with anticoagulants
* Use of any investigational drug within 30 days prior to screening
* History or current use of immunomodulatory therapy for over 2 weeks during the 6 months prior to enrollment, including, but not limited to:
* IFN-α or γ (recombinant or pegylated)
* Systemic corticosteroids (inhaled steroids allowed at the discretion of the Investigator)
* Systemic cancer chemotherapy/irradiation
* cyclosporin; tacrolimus (FK-506)
* OKT-3
* Any Interleukin, including IL-2
* Cyclophosphamide
* Methotrexate
* IVIG (gamma globulin)
* G/M-CSF
* Hydroxyurea
* Thalidomide
* Pentoxifylline
* Thymopentin, thymosin
* Dithiocarbonate
* Polyribonucleoside.
* History of adverse or allergic reactions to any type-1 interferon (e.g. IFN-α2a, IFN-α2b, IFN-β)
* Any other chronic or clinically significant medical condition that in the opinion of investigator would jeopardize the safety or rights of the volunteer, including, clinically significant forms of:
* Drug or alcohol abuse
* Severe asthma
* Uncontrolled hypertension
* Type I diabetes mellitus, or type II diabetes mellitus that is not controlled with oral agents and/or insulin (i.e.: subjects with a history of diabetes mellitus and HA1C of \> 9 in the last 3 months or at screening)
* Psychiatric disorders, including severe depression and/or suicidal ideation
* Heart disease
* Cancer or hematologic malignancies
* Prior diagnosis of multiple sclerosis or other neurodegenerative disorders
* Liver cirrhosis or hepatic decompensation
* Chronic HCV infection (HCV viremia), or HBV Ag positive and/ or HBV viremia (Notice: subjects with prior HCV infection with a documented sustained virologic response at 24 weeks post treatment prior to screening are eligible for enrollment.
* Major organ transplantation with an existing functional graft
* Active autoimmune diseases, including autoimmune hepatitis
* History of retinopathy or clinically significant ophthalmologic disease
* Opportunistic infections or other active infectious diseases
* Other conditions, such as active drug/alcohol abuse or dependence, that in the opinion of the Investigator would interfere with study compliance.
* Initiation of treatment during acute infection
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Pennsylvania
OTHER
Sponsor Role
collaborator
Philadelphia Fight
OTHER
Sponsor Role
collaborator
Rockefeller University
OTHER
Sponsor Role
collaborator
Merck Sharp & Dohme LLC
INDUSTRY
Sponsor Role
collaborator
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Sponsor Role
collaborator
Luis Montaner
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Luis Montaner
Principal Investigator
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Luis J Montaner, DVM, DPhil
Role: PRINCIPAL_INVESTIGATOR
The Wistar Institute
Pablo Tebas, M.D.
Role: STUDY_CHAIR
University of Pennsylvania
Karam Mounzer, M.D.
Role: STUDY_DIRECTOR
Philadelphia Fight
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Site Status
Jonathan Lax Center at Philadelphia FIGHT
Philadelphia, Pennsylvania, United States
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
References
Explore related publications, articles, or registry entries linked to this study.
Azzoni L, Foulkes AS, Papasavvas E, Mexas AM, Lynn KM, Mounzer K, Tebas P, Jacobson JM, Frank I, Busch MP, Deeks SG, Carrington M, O'Doherty U, Kostman J, Montaner LJ. Pegylated Interferon alfa-2a monotherapy results in suppression of HIV type 1 replication and decreased cell-associated HIV DNA integration. J Infect Dis. 2013 Jan 15;207(2):213-22. doi: 10.1093/infdis/jis663. Epub 2012 Oct 26.
Reference Type
BACKGROUND
Caskey M, Schoofs T, Gruell H, Settler A, Karagounis T, Kreider EF, Murrell B, Pfeifer N, Nogueira L, Oliveira TY, Learn GH, Cohen YZ, Lehmann C, Gillor D, Shimeliovich I, Unson-O'Brien C, Weiland D, Robles A, Kummerle T, Wyen C, Levin R, Witmer-Pack M, Eren K, Ignacio C, Kiss S, West AP Jr, Mouquet H, Zingman BS, Gulick RM, Keler T, Bjorkman PJ, Seaman MS, Hahn BH, Fatkenheuer G, Schlesinger SJ, Nussenzweig MC, Klein F. Antibody 10-1074 suppresses viremia in HIV-1-infected individuals. Nat Med. 2017 Feb;23(2):185-191. doi: 10.1038/nm.4268. Epub 2017 Jan 16.
Reference Type
BACKGROUND
Scheid JF, Horwitz JA, Bar-On Y, Kreider EF, Lu CL, Lorenzi JC, Feldmann A, Braunschweig M, Nogueira L, Oliveira T, Shimeliovich I, Patel R, Burke L, Cohen YZ, Hadrigan S, Settler A, Witmer-Pack M, West AP Jr, Juelg B, Keler T, Hawthorne T, Zingman B, Gulick RM, Pfeifer N, Learn GH, Seaman MS, Bjorkman PJ, Klein F, Schlesinger SJ, Walker BD, Hahn BH, Nussenzweig MC, Caskey M. HIV-1 antibody 3BNC117 suppresses viral rebound in humans during treatment interruption. Nature. 2016 Jul 28;535(7613):556-60. doi: 10.1038/nature18929. Epub 2016 Jun 22.
Reference Type
BACKGROUND
Bilger A, Plenn E, Barg FK, Rendle KA, Carter WB, Lamour-Harrington A, Jones N, Peterson B, Sauceda JA, Tebas P, Mounzer K, Metzger D, Montaner LJ, Dube K. Participant experiences in HIV cure-directed trial with an extended analytical treatment interruption in Philadelphia, United States. HIV Res Clin Pract. 2023 Oct 6;24(1):2267825. Epub 2023 Oct 14.
Reference Type
DERIVED
Neergaard R, Jones NL, Roebuck C, Rendle KA, Barbati Z, Peterson B, Tebas P, Mounzer K, Metzger D, Montaner LJ, Dube K, Barg FK. "I Know That I Was a Part of Making a Difference": Participant Motivations for Joining a Cure-Directed HIV Trial with an Analytical Treatment Interruption. AIDS Res Hum Retroviruses. 2023 Aug;39(8):414-421. doi: 10.1089/AID.2022.0040. Epub 2022 Sep 15.
Reference Type
DERIVED
Related Links
Access external resources that provide additional context or updates about the study.
http://beat-hiv.org
Website for the BEAT-HIV Delaney Collaboratory, which is the funding mechanism for the clinical trial outlined in the current registry.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ES 38445
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
PEG-interferon Alfa-2a add-on Study in HBeAg Negative Chronic Hepatitis B Patients
NCT01373684
COMPLETED
PHASE4
PEG-IFN in HBV Patients With Incomplete Response to NA
NCT00883844
COMPLETED
PHASE4
Efficacy of Albumin Interferon Alfa-2b With Ribavirin Compared to Peg-IFN Alfa-2a With Ribavirin in IFN Naive Patients Geno2/3
NCT00411385
COMPLETED
PHASE3
Efficacy and Tolerance of Peg-interferon Alpha 2a Added to Tenofovir and Emtricitabine in AgHBe Positive HBV-HIV Co-infected Patients
NCT00391638
COMPLETED
PHASE2/PHASE3
Combination Therapy of Pegylated Interferon Alfa-2a and Tenofovir Versus Tenofovir Monotherapy in Chronic Hepatitis B
NCT01369212
COMPLETED
PHASE3
A Study of JNJ-73763989, Pegylated Interferon Alpha-2a, Nucleos(t)Ide Analog (NA) With or Without JNJ-56136379 in Treatment-naive Participants With Hepatitis B e Antigen (HBeAg) Positive Chronic Hepatitis B Virus (HBV) Infection
NCT04439539
COMPLETED
PHASE2
Combination or Sequential Therapy of Peginterferon Alfa-2a and Entecavir for Patients With Chronic Hepatitis B
NCT01906580
UNKNOWN
PHASE4
A Study of Peginterferon Alfa-2a (Pegasys) in Participants With Hepatitis B E-Antigen (HBeAg)-Positive Chronic Hepatitis B Virus (HBV)
NCT02604823
COMPLETED
PHASE4
A Phase II Clinical Study of BW-20507 in Combination With PEG-IFNα for the Treatment of Hepatitis B
NCT07135349
ACTIVE_NOT_RECRUITING
PHASE2
The Treatment of PD-1 Antibody Combined With Peg-IFNα in NAs-suppressed CHB Patients
NCT06357806
RECRUITING
NA
Tolerability of Peginterferon Plus Ribavirin for Chronic Hepatitis C and HIV for Patients Receiving Antiretroviral Medication vs Not Receiving Antiretroviral Medication
NCT00296972
TERMINATED
PHASE3
Sequential Combination Therapy With PD-1 Antibody and Peg-IFNα in CHB Patients
NCT06457477
RECRUITING
NA
Efficacy of Extended Peginterferon Alpha 2a Treatment in HBeAg Positive Chronic Hepatitis B Patients
NCT02387463
COMPLETED
Efficay of Extended Peginterferon Alpha 2a Treatment in HBeAg Negative Chronic Hepatitis B Patients
NCT02387684
UNKNOWN
Study of VIR-2218, VIR-3434, and/or PEG-IFNα in Subjects With Chronic Hepatitis B Virus Infection
NCT04856085
ACTIVE_NOT_RECRUITING
PHASE2
A Study to Collect Blood Biomarker Samples From Participants With Chronic Hepatitis B (CHB) Who Received Treatment With Pegasys (Peginterferon Alfa-2a) ± Nucleoside/Nucleotide Analogue
NCT01855997
COMPLETED
A Study of Pegylated Interferon Alfa-2a and Lamivudine in Patients With HBeAg-Negative Chronic Hepatitis B Virus (HBV)
NCT01095835
COMPLETED
PHASE3
A Multicenter Study of AHB-137 Injection Combined With Other Hepatitis B Drugs
NCT07069569
ACTIVE_NOT_RECRUITING
PHASE2
Efficacy and Safety of Peg-Interferon Alpha-2a Plus Ribavirin in Genotype 1 Chronic Hepatitis C Participants Co-Infected With Human Immunodeficiency Virus
NCT02761629
COMPLETED
PHASE4
A Study of 48 Versus 96 Weeks of Peginterferon Alfa-2a [Pegasys] Treatment, With or Without Entecavir, in Patients With Chronic Hepatitis B.
NCT01179594
WITHDRAWN
PHASE4
A Randomized Study to Assess the Loss of HbsAg After a 48-week Treatment Period With Pegylated Interferon Alpha 2a in Patients With Chronic Hepatitis B
NCT01172392
UNKNOWN
PHASE3
A Study of Peginterferon Alfa-2a in Participants With Chronic Hepatitis B Virus (HBV) in an Expanded Access Program
NCT02791269
COMPLETED
PHASE4
A Study of Pegasys (Peginterferon Alfa-2a) Versus Untreated Control in Children With HBeAg Positive Chronic Hepatitis B
NCT01519960
COMPLETED
PHASE3
To Study the Efficacy of PEG-IFN Alpha in HBeAg Negative Chronic Hepatitis B Patients After Stopping Nucleotide Analogue Therapy.
NCT03123653
UNKNOWN
NA
48 Weeks Combination Therapy for Patients With HBeAg-negative Chronic Hepatitis B Virus (HBV) Infection
NCT00114361
COMPLETED
PHASE3