HIV-1 InfectionPhase 2NCT01935089
Pilot Peg-Interferon-a2b in Decreasing Viral DNA in HIV
A Phase 2 study testing Pegylated Interferon alpha 2b in people with HIV-1 Infection, run by The Wistar Institute at 3 sites in United States.
Trial summary
We propose to test our primary hypothesis that treatment with Peg-IFN-α-2b will result in a decrease in integrated HIV DNA in peripheral blood and tissue in chronically HIV-infected immune-reconstituted individuals (see section 3.1) in a prospective, interventional, 1-arm, open label clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV-1 Infection
- What is being tested?
- Pegylated Interferon alpha 2b
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- 7 Aug 2013to 2 May 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years of age
- Body weight between 125 and 299 lbs
- Confirmed diagnosis of HIV-1 infection by western blot or by a documented HIV-1 viral load
- Currently receiving ART and on ART for > 1 year
- VL < 50 copies/ml for ≥ 1 year, with at least 2 measurements in the previous year, 1 viral "blip" with VL< 400 copies/ml allowed
- HIV viral load of <50 copies/ml at screening.
- CD4 >450 cells/µL at screening.
- A negative ECG if >45yrs men/>55yrs women years of age or if below these years of age but with two added 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)] or a Framingham score > 15% (men) or 10% (women))
Who cannot join
- 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 Isoniazide, pyrazinamide, Rifabutin, Rifampicin, Diadenosine Ganciclovir, Valgancyclovir, Oxymetholone, Thalidomide or Theophylline.
- 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-alpha or gamma (recombinant or pegylated), systemic corticosteroids (nasal or pulmonary steroids will be allowed; 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; polyribonucleotide.
- History of adverse or allergic reactions to any type-1 interferon (e.g. IFN-alpha2a, IFN-α2b, IFN-beta)
Show all 25Show fewer
- History of severe depression, or ongoing moderate depression determined by PHQ-9 at screening
- Type I diabetes mellitus, or type II diabetes mellitus that is not controlled with oral agents and/or insulin.
- Prior diagnosis of multiple sclerosis or other neurodegenerative disorders
- Significant co-existing lab abnormalities including:
- Anemia (Hgb <9.1 mg/dl men, <8.9 mg/dl women)
- WBC <2000 cells/µl
- Absolute neutrophil count (ANC) <1200 cells/ µl
- Platelet count <60,000 cells/ µl
- Liver disease (AST/ALT > 2.5x, Total Bilirubin > 1.5x upper limits of norm (ULN), or Total Bilirubin >3x ULN if receiving indinavir OR Atazanavir)
- Renal disease (creatinine > 2x upper normal limits or creatinine clearance <60mg/dl (by Crockoff-Gault)
- 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 with treatment finishing >1 year prior to screening are eligible for enrollment).
- Liver cirrhosis or hepatic decompensation with Child Pugh score > 6
- History of major organ transplantation with an existing functional graft.
- Evidence of OI or other active infectious diseases or active malignancies
- Active Autoimmune diseases, including autoimmune hepatitis
- History of retinopathy or clinically significant ophthalmologic disease on eye exam performed within 6 months prior to initiation of IFN
- Pregnancy, actively attempting to become pregnant, or breastfeeding
- Body weight under 125 lbs or over 300 lbs
- Other conditions, such as active drug/alcohol abuse or dependence which would interfere with study compliance
Trial locations and contacts
3 sites in 1 country.
United States3 sites
AIDS Clinical Trials Unit (ACTU), and Department of Medicine, University of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania, 19104
Presbyterian Hospital, Department of Medicine, University of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania, 19104
Jonathan Lax Clinic, Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107
About this study
Official title: Pilot Study: Single Arm, Multi-site, Open-label Study to Assess the Effectiveness of Peg-IFN-a2b in Decreasing the Levels of Cell-associated Integrated Viral DNA in HIV Chronic Infection
We propose to test our primary hypothesis that treatment with Peg-IFN-α-2b will result in a decrease in integrated HIV DNA in peripheral blood and tissue in chronically HIV-infected immune-reconstituted individuals (see section 3.1) in a prospective, interventional, 1-arm, open label clinical trial. To this end, we propose to enroll 25 HIV-1-infected subjects (please refer to power calculations in section 10.1 below) currently stably suppressed (> 1y with VL < 50 copies/ml) on ART and with CD4 count > 450 cells/µl.
We hypothesize that 20 weeks of treatment with Peg-IFN-alpha-2b, in the presence of HIV reactivation (i.e.: ART interruption), will result in activation of intrinsic and/or immune-mediated anti-HIV mechanisms resulting in a decrease in the levels of viral reservoir in chronically HIV-infected, immune-reconstituted individuals.
- Conditions
- HIV-1 Infection
- Being tested
- Pegylated Interferon alpha 2b
- Keywords
- HIV-1, Interferon alpha, Integrated DNA, Latent reservoir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated Interferon alpha 2bDrug
Also called Pegintron
1µg/kg/week
| Study group | Role | What they receive |
|---|---|---|
| Interferon alpha | Experimental | pegylated Interferon alpha 2b (Pegintron) 1 µg/kg per week, 20 weeks Receives: Drug: Pegylated Interferon alpha 2b |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Copies of HIV DNA Per CD4+ T Cell at Week 24
Difference in copies of HIV DNA per CD4+ T cell between baseline and week 24, assessed by Alu-HIVgag polymerase chain reaction
Measured: Week 3 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2013 (estimated)
- Study start7 Aug 2013
- Primary completion25 Mar 2015
- Study completion2 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV-1 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Wistar Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Luis Montaner, The Wistar Institute
- Investigators
- Luis J Montaner, DPhil, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01935089
- Sponsor's protocol ID
- Merck-0575
- Status last verified
- Jul 2023
- First submitted
- 27 Aug 2013
- Last updated
- 6 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Papasavvas E, Azzoni L, Ross BN, Fair M, Howell BJ, Hazuda DJ, Mounzer K, Kostman JR, Tebas P, Montaner LJ. Comparable HIV suppression by pegylated-IFN-alpha2a or pegylated-IFN-alpha2b during a 4-week analytical treatment interruption. AIDS. 2021 Oct 1;35(12):2051-2054. doi: 10.1097/QAD.0000000000002961.
PubMed 34049356Papasavvas E, Azzoni L, Pagliuzza A, Abdel-Mohsen M, Ross BN, Fair M, Howell BJ, Hazuda DJ, Chomont N, Li Q, Mounzer K, Kostman JR, Tebas P, Montaner LJ. Safety, Immune, and Antiviral Effects of Pegylated Interferon Alpha 2b Administration in Antiretroviral Therapy-Suppressed Individuals: Results of Pilot Clinical Trial. AIDS Res Hum Retroviruses. 2021 Jun;37(6):433-443. doi: 10.1089/AID.2020.0243. Epub 2021 Jan 29.
PubMed 33323024
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Single Arm, Multi-site, Open-label Study to Assess the Effectiveness of Peg-IFN-a2b in Decreasing the Levels of Cell-associated Integrated Viral DNA in HIV Chronic Infection
- ClinicalTrials.gov ID
- NCT01935089
- Acronym / sponsor ID
- Merck-0575
- Conditions
- HIV-1 Infection
- Keywords
- HIV-1, Interferon alpha, Integrated DNA, Latent reservoir
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The Wistar InstituteUniversity, hospital or other
- Collaborators
- University of Pennsylvania, Merck Sharp & Dohme LLC
- Study start
- 7 Aug 2013
- Primary completion
- 25 Mar 2015 (actual)
- Study completion
- 2 May 2016 (actual)
- First posted
- 4 Sep 2013 (estimated)
- Results
- Posted 6 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We propose to test our primary hypothesis that treatment with Peg-IFN-α-2b will result in a decrease in integrated HIV DNA in peripheral blood and tissue in chronically HIV-infected immune-reconstituted individuals (see section 3.1) in a prospective, interventional, 1-arm, open label clinical trial. To this end, we propose to enroll 25 HIV-1-infected subjects (please refer to power calculations in section 10.1 below) currently stably suppressed (> 1y with VL < 50 copies/ml) on ART and with CD4 count > 450 cells/µl.
We hypothesize that 20 weeks of treatment with Peg-IFN-alpha-2b, in the presence of HIV reactivation (i.e.: ART interruption), will result in activation of intrinsic and/or immune-mediated anti-HIV mechanisms resulting in a decrease in the levels of viral reservoir in chronically HIV-infected, immune-reconstituted individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interferon alpha | Experimental | Drug: Pegylated Interferon alpha 2bpegylated Interferon alpha 2b (Pegintron) 1 µg/kg per week, 20 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18-65 years of age
- Body weight between 125 and 299 lbs
- Confirmed diagnosis of HIV-1 infection by western blot or by a documented HIV-1 viral load
- Currently receiving ART and on ART for > 1 year
- VL < 50 copies/ml for ≥ 1 year, with at least 2 measurements in the previous year, 1 viral "blip" with VL< 400 copies/ml allowed
Key exclusion criteria (25 listed)
- 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 Isoniazide, pyrazinamide, Rifabutin, Rifampicin, Diadenosine Ganciclovir, Valgancyclovir, Oxymetholone, Thalidomide or Theophylline.
- 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-alpha or gamma (recombinant or pegylated), systemic corticosteroids (nasal or pulmonary steroids will be allowed; 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; polyribonucleotide.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pegylated Interferon alpha 2bAlso: Pegintron1µg/kg/week | Drug | Interferon alpha |
Primary outcome
Change From Baseline in Copies of HIV DNA Per CD4+ T Cell at Week 24
Time frame: Week 3 and 24
Difference in copies of HIV DNA per CD4+ T cell between baseline and week 24, assessed by Alu-HIVgag polymerase chain reaction
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34049356Papasavvas E, Azzoni L, Ross BN, Fair M, Howell BJ, Hazuda DJ, Mounzer K, Kostman JR, Tebas P, Montaner LJ. Comparable HIV suppression by pegylated-IFN-alpha2a or pegylated-IFN-alpha2b during a 4-week analytical treatment interruption. AIDS. 2021 Oct 1;35(12):2051-2054. doi: 10.1097/QAD.0000000000002961.
- Derived from this study: PubMed 33323024Papasavvas E, Azzoni L, Pagliuzza A, Abdel-Mohsen M, Ross BN, Fair M, Howell BJ, Hazuda DJ, Chomont N, Li Q, Mounzer K, Kostman JR, Tebas P, Montaner LJ. Safety, Immune, and Antiviral Effects of Pegylated Interferon Alpha 2b Administration in Antiretroviral Therapy-Suppressed Individuals: Results of Pilot Clinical Trial. AIDS Res Hum Retroviruses. 2021 Jun;37(6):433-443. doi: 10.1089/AID.2020.0243. Epub 2021 Jan 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis J Montaner, DPhil principal investigator
University of Pennsylvania
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pegylated Interferon alpha 2b in people with HIV-1 Infection, run by The Wistar Institute at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Copies of HIV DNA Per CD4+ T Cell at Week 24 (time frame: Week 3 and 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01935089, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023.