HIV/AIDSPhase 2NCT04819347
Albuvirtide in Combination With 3BNC117 in Virologically Suppressed Subjects With HIV-1 Infection
A Phase 2 study testing Albuvirtide and 3BNC117 in people with HIV/AIDS, run by Frontier Biotechnologies Inc. at 1 site in China.
Trial summary
This is a phase 2 study to evaluate the safety and tolerability of combination therapy with Albuvirtide (ABT) and 3BNC117 in virologically suppressed subjects with HIV-1 infection and explore the potential of viral suppression and viral reservoir clearance after analytical treatment interruption (ATI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Albuvirtide and 3BNC117
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to 1 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females, age ≥18 years
- For cohort 1: HIV-1 infected subjects initiated a stable combination antiretroviral therapy (ART) within 6 months of primary HIV infection (PHI), having the document evidence of initial diagnosis of HIV-1 infection and initiation of ART therapy within 6 months of PHI.
- For cohort 2: Chronically HIV-1 infected subjects initiated a stable combination antiretroviral therapy (ART) after 6 months of primary HIV infection (PHI), having the document evidence of initial diagnosis of HIV-1 infection and initiation of ART therapy after 6 months of PHI.
- Plasma HIV-1 RNA <50 copies/mL for at least 12 months prior to Screening Visit. An exception for a recorded HIV-1 RNA "blip" (e.g., transient HIV-1 RNA >50 copies/mL) can be considered.
- Plasma HIV-1 RNA <20 copies/mL at Screening Visit.
- CD4 cell count >500 cells/µL.
Show all 19Show fewer
- Laboratory values at Screening of:
- Absolute neutrophil count (ANC) ≥0.75×10∧9/L;
- Hemoglobin (Hb) ≥105 g/L (male) or ≥95 g/L (female);
- Platelets ≥75×10∧9/L;
- Serum alanine transaminase (SGPT/ALT) < 2 x upper limit of normal (ULN)
- Serum aspartate transaminase (SGOT/AST) < 2 x ULN
- Bilirubin (total) <2.5 x ULN unless Gilbert's disease is present or subject is receiving atazanavir in the absence of other evidence of significant liver disease
- Creatinine ≤1.5 x ULN
- Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
- Both male and female patients and their partners of childbearing potential must agree to use accepted methods of contraception.
- Females of childbearing potential must have a negative serum pregnancy test at Screening visit and negative urine pregnancy test prior to receiving the first dose of study drug.
- Subjects who have two or more potential alternative antiretroviral treatment regimens.
- Willing and able to participate in all aspects of the study, including use of IV medication, completion of evaluations, attendance at scheduled clinic visits, and compliance with all protocol requirements as evidenced by providing written informed consent.
Who cannot join
- Any active infection or malignancy requiring acute therapy.
- Hepatitis B infection as manifest by the presence of Hepatitis B surface antigen (HBsAg).
- Hepatitis C infection as manifest by positive anti-HCV antibody and positive HCV RNA assay at the time of screening.
- Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study
- Unexplained fever or clinically significant illness within 1 week prior to the first study dose
- Any vaccination within 2 weeks prior to the first study dose.
Show all 18Show fewer
- Subjects BMI<20 or >27 kg/m∧2 [BMI＝weight/height∧2].
- History of Bleeding Disorder or patients on anti-coagulant therapy
- Participation in an experimental drug trial(s) within 30 days of the Screening Visit
- Any known allergy or antibodies to the study drug or excipients
- Treatment with any of the following:
- Radiation or cytotoxic chemotherapy with 30 days prior to the screening visit
- Receipt of any fusion inhibitor and monoclonal antibody therapy of any kind in the past.
- Immunosuppressants within 60 days prior to the Screening Visit
- Immunomodulating agents (e.g., interleukins, interferons), hydroxyurea, or foscarnet within 60 days prior to the screening visit
- Oral or parenteral corticosteroids within 30 days prior to the Screening Visit. Subjects on chronic steroid therapy > 5 mg/day will be excluded with the following exception:
- Subjects on inhaled, nasal, or topical steroids will not be excluded
- Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.
Trial locations and contacts
1 site in 1 country.
Cheng Yao contact
China1 site
Peking Union Medical College Hospital
Beijing
Taisheng Li, M.D., litsh@263.net
Taisheng Li, M.D.
About this study
Official title: The Phase 2, Two Arms, One Site, Safety and Antiviral Activity of Combination Therapy With Albuvirtide and 3BNC117 in Virologically Suppressed Subjects With HIV-1 Infection After Analytical Treatment Interruption
This is a phase 2 study to evaluate the safety and tolerability of combination therapy with Albuvirtide (ABT) and 3BNC117 in virologically suppressed subjects with HIV-1 infection and explore the potential of viral suppression and viral reservoir clearance after analytical treatment interruption (ATI).
Read the detailed description
This is an open-label, one site study, in which a total of 24 HIV-1 subjects who are virologically suppressed and stable on daily oral combination antiretroviral therapy will be enrolled.
All eligible patients will be switched from daily oral combination antiretroviral regimen to treatment of ABT and 3BNC117 for 14 weeks. There is a two-week overlap of the baseline oral antiretroviral therapy and the ABT-3BNC117 combination regimen at the beginning of the study treatment, and then the oral ART will be interrupted.
The patients will be monitored for viral rebound every two or four weeks following initiation of ABT-3BNC117 combination and will re-initiate an oral antiretroviral regimen if virological rebound is confirmed with plasma HIV-1 RNA levels above 200 copies/ml on two consecutive test.
Pharmacokinetics of ABT and 3BNC117 will be assessed in this study.
- Conditions
- HIV/AIDS
- Being tested
- Albuvirtide, 3BNC117
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlbuvirtideDrug
Also called ABT
Long-Acting HIV-1 Fusion Inhibitor (chemically modified peptide targeting HIV-1 gp41)
3BNC117Drug
Recombinant, fully human mAb of the IgG1κ isotype that specifically binds to HIV-1 gp120.
| Study group | Role | What they receive |
|---|---|---|
| Early treatment of infection | Experimental | HIV-1 infected subjects initiated a stable combination antiretroviral therapy (ART) within 6 months of primary HIV infection (PHI), and had plasma HIV-1 RNA <50 copies/mL for at least 12 months.
Albuvirtide 0.32 g and 3BNC117 2 g every 2 weeks IV infusion for a total of 14 weeks. Receives: Drug: Albuvirtide; Drug: 3BNC117 |
| Chronic period of infection treatment | Experimental | Chronically HIV-1 infected subjects initiated a stable combination antiretroviral therapy (ART) after 6 months of primary HIV infection (PHI), and had plasma HIV-1 RNA <50 copies/mL for at least 12 months.
Albuvirtide 0.32 g and 3BNC117 2 g every 2 weeks IV infusion for a total of 14 weeks. Receives: Drug: Albuvirtide; Drug: 3BNC117 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants (with sustained viral suppression at week 14) with HIV-1 RNA < 50 copies/mL at Week 26 (24 weeks after ATI)
Proportion of participants with HIV-1 RNA < 50 copies/mL at Week 26.
Measured: Week 26
Secondary outcomes (7)
Mean time to virologic rebound (HIV-1 RNA≥200 copies/mL) after ATI
Mean time to virologic rebound
Measured: up to 48 weeks
Proportion of participants without experiencing virologic rebound (HIV-1 RNA<200 copies/mL) at Week 26 (24 weeks after ATI).
Proportion of participants without experiencing virologic rebound
Measured: Week 26
Proportion of participants with HIV-1 RNA < 50 copies/mL at Week 26 (24 weeks after ATI).
Proportion of participants with HIV-1 RNA < 50 copies/mL at Week 26
Measured: Week 26
Mean change in CD4 cell count after ATI
Mean change in CD4 cell count
Measured: up to 48 weeks
Mean change in CD4/CD8 ration after ATI
Mean change in CD4/CD8 ration
Measured: up to 48weeks
Frequency of emergence of new resistance mutations after virologic rebound
Frequency of emergence of new resistance mutations
Measured: up to 48 weeks
Mean time to achieving HIV-1 RNA < 50 copies/mL after experiencing virologic rebound
Mean time to achieving HIV-1 RNA < 50 copies/mL after experiencing virologic rebound
Measured: up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start1 May 2021 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Frontier Biotechnologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cheng Yao, Study director, Frontier Biotechnologies Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04819347
- Sponsor's protocol ID
- ABT-3BNC117_202
- Status last verified
- Mar 2021
- First submitted
- 22 Mar 2021
- Last updated
- 26 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Phase 2, Two Arms, One Site, Safety and Antiviral Activity of Combination Therapy With Albuvirtide and 3BNC117 in Virologically Suppressed Subjects With HIV-1 Infection After Analytical Treatment Interruption
- ClinicalTrials.gov ID
- NCT04819347
- Acronym / sponsor ID
- ABT-3BNC117_202
- Conditions
- HIV/AIDS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Frontier Biotechnologies Inc.Industry (pharma, biotech, devices)
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 2 study to evaluate the safety and tolerability of combination therapy with Albuvirtide (ABT) and 3BNC117 in virologically suppressed subjects with HIV-1 infection and explore the potential of viral suppression and viral reservoir clearance after analytical treatment interruption (ATI).
Detailed description
This is an open-label, one site study, in which a total of 24 HIV-1 subjects who are virologically suppressed and stable on daily oral combination antiretroviral therapy will be enrolled.
All eligible patients will be switched from daily oral combination antiretroviral regimen to treatment of ABT and 3BNC117 for 14 weeks. There is a two-week overlap of the baseline oral antiretroviral therapy and the ABT-3BNC117 combination regimen at the beginning of the study treatment, and then the oral ART will be interrupted.
The patients will be monitored for viral rebound every two or four weeks following initiation of ABT-3BNC117 combination and will re-initiate an oral antiretroviral regimen if virological rebound is confirmed with plasma HIV-1 RNA levels above 200 copies/ml on two consecutive test.
Pharmacokinetics of ABT and 3BNC117 will be assessed in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early treatment of infection | Experimental | Drug: Albuvirtide, Drug: 3BNC117HIV-1 infected subjects initiated a stable combination antiretroviral therapy (ART) within 6 months of primary HIV infection (PHI), and had plasma HIV-1 RNA <50 copies/mL for at least 12 months. Albuvirtide 0.32 g and 3BNC117 2 g every 2 weeks IV infusion for a total of 14 weeks. |
| Chronic period of infection treatment | Experimental | Drug: Albuvirtide, Drug: 3BNC117Chronically HIV-1 infected subjects initiated a stable combination antiretroviral therapy (ART) after 6 months of primary HIV infection (PHI), and had plasma HIV-1 RNA <50 copies/mL for at least 12 months. Albuvirtide 0.32 g and 3BNC117 2 g every 2 weeks IV infusion for a total of 14 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Males and females, age ≥18 years
- For cohort 1: HIV-1 infected subjects initiated a stable combination antiretroviral therapy (ART) within 6 months of primary HIV infection (PHI), having the document evidence of initial diagnosis of HIV-1 infection and initiation of ART therapy within 6 months of PHI.
- For cohort 2: Chronically HIV-1 infected subjects initiated a stable combination antiretroviral therapy (ART) after 6 months of primary HIV infection (PHI), having the document evidence of initial diagnosis of HIV-1 infection and initiation of ART therapy after 6 months of PHI.
- Plasma HIV-1 RNA <50 copies/mL for at least 12 months prior to Screening Visit. An exception for a recorded HIV-1 RNA "blip" (e.g., transient HIV-1 RNA >50 copies/mL) can be considered.
- Plasma HIV-1 RNA <20 copies/mL at Screening Visit.
Key exclusion criteria (18 listed)
- Any active infection or malignancy requiring acute therapy.
- Hepatitis B infection as manifest by the presence of Hepatitis B surface antigen (HBsAg).
- Hepatitis C infection as manifest by positive anti-HCV antibody and positive HCV RNA assay at the time of screening.
- Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study
- Unexplained fever or clinically significant illness within 1 week prior to the first study dose
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 |
|---|---|---|
| AlbuvirtideAlso: ABTLong-Acting HIV-1 Fusion Inhibitor (chemically modified peptide targeting HIV-1 gp41) | Drug | Chronic period of infection treatment, Early treatment of infection |
| 3BNC117Recombinant, fully human mAb of the IgG1κ isotype that specifically binds to HIV-1 gp120. | Drug | Chronic period of infection treatment, Early treatment of infection |
Primary outcome
Proportion of participants (with sustained viral suppression at week 14) with HIV-1 RNA < 50 copies/mL at Week 26 (24 weeks after ATI)
Time frame: Week 26
Proportion of participants with HIV-1 RNA < 50 copies/mL at Week 26.
7 secondary outcomes
Mean time to virologic rebound (HIV-1 RNA≥200 copies/mL) after ATI
Time frame: up to 48 weeks
Proportion of participants without experiencing virologic rebound (HIV-1 RNA<200 copies/mL) at Week 26 (24 weeks after ATI).
Time frame: Week 26
Proportion of participants with HIV-1 RNA < 50 copies/mL at Week 26 (24 weeks after ATI).
Time frame: Week 26
Mean change in CD4 cell count after ATI
Time frame: up to 48 weeks
Mean change in CD4/CD8 ration after ATI
Time frame: up to 48weeks
Frequency of emergence of new resistance mutations after virologic rebound
Time frame: up to 48 weeks
Mean time to achieving HIV-1 RNA < 50 copies/mL after experiencing virologic rebound
Time frame: up to 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for HIV/AIDS
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Cheng Yao contact
Cheng Yao study director
Frontier Biotechnologies Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Albuvirtide and 3BNC117 in people with HIV/AIDS, run by Frontier Biotechnologies Inc. at 1 site in China.
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 19 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 26 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xingxiang Xu (025-69648410, xxxu@frontierbiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants (with sustained viral suppression at week 14) with HIV-1 RNA < 50 copies/mL at Week 26 (24 weeks after ATI) (time frame: Week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Mar 2021.