HIV/AIDSPhase 2NCT04560569
Albuvirtide in Combination With 3BNC117 in Patients With Multi-Drug Resistant (MDR) HIV-1 Infection
A Phase 2 study testing Albuvirtide and 3BNC117 Antibody in people with HIV/AIDS, run by Frontier Biotechnologies Inc. at 7 sites in United States.
Trial summary
The primary objectives are to assess the antiviral activity, clinical safety and tolerability parameters of albuvirtide/3BNC117 combination therapy in reducing HIV-1 viral load during the 1-week induction period treatment period. 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 Antibody
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 7 sitesUnited States
- Study dates
- 30 Nov 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;
- HIV-1 seropositive with documented HIV-1 infection by official, signed, written history (e.g. Laboratory report)
- Receiving a combination antiretroviral therapy (cART) (failing regimen) for at least 8 weeks before Screening and are willing to continue on the failing regimen during the Screening Phase and up to Day 14 of the Treatment Phase, OR have failed in the past 8 weeks of Screening, are off therapy and are willing to stay off therapy until Day 14 of the Treatment Phase;
- Plasma HIV-1 RNA ≥ 1000 copies/mL at the Screening Visit and documented detectable viral load (HIV-1 RNA >200 copies/ml) within the last 3 months prior to the Screening Visit;
- Highly treatment-experienced HIV-infected patients with genotypic and/or phenotypic resistance to at least one ARV drug for each of three or more drug classes of antiretroviral medications at the Screening Visit and have difficulty in constructing a viable suppressive regimen;
- Have full viral sensitivity/susceptibility to at least one approved antiretroviral agent, other than ABT and 3BNC117, as determined by genotypic and/or phenotypic ARV drug resistance tests at screening, and such agent can be used as a component of OBR;
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- Be willing to remain on treatment without any changes or additions to the OBR regimen, except for toxicity management or upon meeting criteria for treatment failure;
- Have a life expectancy that is > 9 months;
- Laboratory values at Screening of:
- Absolute neutrophil count (ANC) ≥ 750/mm3;
- Hemoglobin (Hb) ≥ 10.5 gm/dL (male) or ≥ 9.5 gm/dL (female);
- Platelets ≥ 75,000 /mm3;
- Serum alanine transaminase (SGPT/ALT) < 1.25 x upper limit of normal (ULN);
- Serum aspartate transaminase (SGOT/AST) < 1.25 x ULN;
- Serum total bilirubin within normal range; and
- Creatinine ≤ 1.5 x ULN.
- Clinically normal resting 12-lead electrocardiogram (ECG) at the 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 2 medically accepted methods of contraception (e.g., barrier contraceptives [male condom, female condom, or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], and intrauterine devices) during the course of the study (excluding women who are not of childbearing potential and men who have been sterilized). Females of childbearing potential must have a negative serum pregnancy test at the Screening visit and negative urine pregnancy test prior to receiving the first dose of study drug; and
- Willing and able to participate in all aspects of the study, including use of IV medication, completion of subjective evaluations, attendance at scheduled clinic visits, and compliance with all protocol requirements as evidenced by providing written informed consent.
- Note: Subjects diagnosed with either substance dependence or substance abuse or any history of a concomitant condition (e.g., medical, psychological, or psychiatric) may be enrolled if, in the opinion of site investigator these circumstances would not interfere with the subject's successful completion of the study requirements.
Who cannot join
- Subject having ≥0.5 log10 reduction in HIV-1 RNA viral load from the Screening Visit to Baseline Visit (Day 0).
- Note: This criterion will be evaluated prior to randomization at T1 Visit (Day 7).
- 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;
- Grade 4 DAIDS laboratory abnormality;
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- 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;
- Prior exposure to albuvirtide or 3BNC117
- Subjects weighing <35kg;
- History of anaphylaxis to any oral or parenteral drugs;
- Use of any fusion inhibitors (T20) and broadly neutralizing monoclonal antibody prior to the Screening Visit, including the investigational drugs, or having documented genotypic and/or phenotypic resistance to fusion inhibitors;
- 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;
- Immunosuppressants or immunomodulating agents within 60 days prior to the screening visit; or
- 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
7 sites in 1 country.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
ABT-3BNC117_203 Investigational Site
Canoga Park, California, 91309
- Recruiting
ABT-3BNC117_203 Investigational Site
Decatur, Georgia, 30030
- Recruiting
ABT-3BNC117_203 Investigational Site
Hialeah, Florida, 33016
- Recruiting
ABT-3BNC117_203 Investigational Site
Orlando, Florida, 32803
- Recruiting
ABT-3BNC117_203 Investigational Site
San Francisco, California, 94115
- Recruiting
ABT-3BNC117_203 Investigational Site
St Louis, Missouri, 63108
- Recruiting
ABT-3BNC117_203 Investigational Site
West Palm Beach, Florida, 33407
About this study
Official title: A Multicenter, Two-Arm, 24-Week Study of Albuvirtide in Combination With 3BNC117 in Patients With Multi-Drug Resistant (MDR) HIV-1 Infection
The primary objectives are to assess the antiviral activity, clinical safety and tolerability parameters of albuvirtide/3BNC117 combination therapy in reducing HIV-1 viral load during the 1-week induction period treatment period.
Read the detailed description
This is a Phase 2, multi-center study to evaluate the efficacy, safety, and tolerability of ABT/3BNC117 combination in conjunction with an existing failing antiretroviral therapy (ART) for 1 week, and then with optimized background regimen (OBR) for 24 weeks, respectively. A total of 20 eligible subjects who demonstrate evidence of HIV-1 replication despite ongoing antiretroviral therapy with documented genotypic and/or phenotypic resistance to multiple classes of HIV drugs (3 classes or more) will be enrolled. Patients must have been treated with HAART for at least 6 months and be failing or have recently failed (i.e., in the last 8 weeks) therapy to determine baseline viral load.
- Conditions
- HIV/AIDS
- Being tested
- Albuvirtide, 3BNC117 Antibody
- 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)
3BNC117 AntibodyDrug
Also called 3BNC117
Recombinant, fully human mAb of the IgG1κ isotype that specifically binds to HIV-1 gp120
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | ABT weekly and 3BNC117 bi-weekly Receives: Drug: Albuvirtide; Drug: 3BNC117 Antibody |
| Group B | Experimental | both ABT and 3BNC117 treatment bi-weekly Receives: Drug: Albuvirtide; Drug: 3BNC117 Antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with ≥0.5 log10 reduction in HIV-1 RNA viral load from baseline (Day 7) to Day 14 as compared to the control period from Day 0 to Day 7.
Proportion of participants (%) achieving a viral load reduction of at least 0.5 log from baseline (Day 7)
Measured: Day 14
Secondary outcomes (6)
Mean change in HIV-1 RNA levels (log10 copies/mL) from baseline (Day 7) to Day 14 as compared to the control period from Day 0 to Day 7.
Mean change in HIV-1 RNA levels from Day 7 to Day 14
Measured: Day 14
Mean change in CD4+/CD8+ T cell count from baseline (Day 7) to Day 14 as compared to the control period from Day 0 to Day 7.
Mean change in CD4+/CD8+ T cell count from Day 7 to Day 14
Measured: Day 14
Percentage of participants achieving HIV-1 RNA <200 copies/mL at the EOT.
Percentage of participants achieving HIV-1 RNA <200 copies/mL
Measured: Week 25/EOT
Mean change in HIV-1 RNA levels (log10 copies/mL) during the course of Treatment Phase
Mean change in HIV-1 RNA levels from Day 0 to EOT
Measured: Through Week 25/EOT
Mean change in HIV-1 RNA levels (log10 copies/mL) from baseline (Day 7) to EOT.
Mean change in HIV-1 RNA levels from Day 7 to EOT
Measured: Week 25/EOT
Mean change in CD4+/CD8+ T cell count from baseline (Day 7) to EOT.
Mean change in CD4+/CD8+ T cell count from Day 7 to EOT
Measured: Week 25/EOT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start30 Nov 2021 (estimated)
- Primary completion1 Nov 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Frontier Biotechnologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cheng Yao, M.D., Study director, Frontier Biotechnologies Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04560569
- Sponsor's protocol ID
- ABT-3BNC117_203
- Status last verified
- Jan 2021
- First submitted
- 17 Sep 2020
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhou Y, Qin Y, Liu X, Zhao Q, Wang M, Chen Y, Li Y, He K, Li X, Harypursat V, Xie D, Chen Y. Albuvirtide plus 3BNC117 provides a promising combination strategy for multidrug-resistant HIV-1 infection: a prospective, open-label, multicenter phase 2 trial. BMC Infect Dis. 2026 Mar 28;26(1):911. doi: 10.1186/s12879-026-12987-3.
PubMed 41896772
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Two-Arm, 24-Week Study of Albuvirtide in Combination With 3BNC117 in Patients With Multi-Drug Resistant (MDR) HIV-1 Infection
- ClinicalTrials.gov ID
- NCT04560569
- Acronym / sponsor ID
- ABT-3BNC117_203
- Conditions
- HIV/AIDS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Frontier Biotechnologies Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Nov 2021 (estimated)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 23 Sep 2020 (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.
The primary objectives are to assess the antiviral activity, clinical safety and tolerability parameters of albuvirtide/3BNC117 combination therapy in reducing HIV-1 viral load during the 1-week induction period treatment period.
Detailed description
This is a Phase 2, multi-center study to evaluate the efficacy, safety, and tolerability of ABT/3BNC117 combination in conjunction with an existing failing antiretroviral therapy (ART) for 1 week, and then with optimized background regimen (OBR) for 24 weeks, respectively. A total of 20 eligible subjects who demonstrate evidence of HIV-1 replication despite ongoing antiretroviral therapy with documented genotypic and/or phenotypic resistance to multiple classes of HIV drugs (3 classes or more) will be enrolled. Patients must have been treated with HAART for at least 6 months and be failing or have recently failed (i.e., in the last 8 weeks) therapy to determine baseline viral load.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Albuvirtide, Drug: 3BNC117 AntibodyABT weekly and 3BNC117 bi-weekly |
| Group B | Experimental | Drug: Albuvirtide, Drug: 3BNC117 Antibodyboth ABT and 3BNC117 treatment bi-weekly |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Males and females, age ≥ 18 years;
- HIV-1 seropositive with documented HIV-1 infection by official, signed, written history (e.g. Laboratory report)
- Receiving a combination antiretroviral therapy (cART) (failing regimen) for at least 8 weeks before Screening and are willing to continue on the failing regimen during the Screening Phase and up to Day 14 of the Treatment Phase, OR have failed in the past 8 weeks of Screening, are off therapy and are willing to stay off therapy until Day 14 of the Treatment Phase;
- Plasma HIV-1 RNA ≥ 1000 copies/mL at the Screening Visit and documented detectable viral load (HIV-1 RNA >200 copies/ml) within the last 3 months prior to the Screening Visit;
- Highly treatment-experienced HIV-infected patients with genotypic and/or phenotypic resistance to at least one ARV drug for each of three or more drug classes of antiretroviral medications at the Screening Visit and have difficulty in constructing a viable suppressive regimen;
Key exclusion criteria (21 listed)
- Subject having ≥0.5 log10 reduction in HIV-1 RNA viral load from the Screening Visit to Baseline Visit (Day 0).
- Note: This criterion will be evaluated prior to randomization at T1 Visit (Day 7).
- 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;
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 | Group A, Group B |
| 3BNC117 AntibodyAlso: 3BNC117Recombinant, fully human mAb of the IgG1κ isotype that specifically binds to HIV-1 gp120 | Drug | Group A, Group B |
Primary outcome
Proportion of participants with ≥0.5 log10 reduction in HIV-1 RNA viral load from baseline (Day 7) to Day 14 as compared to the control period from Day 0 to Day 7.
Time frame: Day 14
Proportion of participants (%) achieving a viral load reduction of at least 0.5 log from baseline (Day 7)
6 secondary outcomes
Mean change in HIV-1 RNA levels (log10 copies/mL) from baseline (Day 7) to Day 14 as compared to the control period from Day 0 to Day 7.
Time frame: Day 14
Mean change in CD4+/CD8+ T cell count from baseline (Day 7) to Day 14 as compared to the control period from Day 0 to Day 7.
Time frame: Day 14
Percentage of participants achieving HIV-1 RNA <200 copies/mL at the EOT.
Time frame: Week 25/EOT
Mean change in HIV-1 RNA levels (log10 copies/mL) during the course of Treatment Phase
Time frame: Through Week 25/EOT
Mean change in HIV-1 RNA levels (log10 copies/mL) from baseline (Day 7) to EOT.
Time frame: Week 25/EOT
Mean change in CD4+/CD8+ T cell count from baseline (Day 7) to EOT.
Time frame: Week 25/EOT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Derived from this study: PubMed 41896772Zhou Y, Qin Y, Liu X, Zhao Q, Wang M, Chen Y, Li Y, He K, Li X, Harypursat V, Xie D, Chen Y. Albuvirtide plus 3BNC117 provides a promising combination strategy for multidrug-resistant HIV-1 infection: a prospective, open-label, multicenter phase 2 trial. BMC Infect Dis. 2026 Mar 28;26(1):911. doi: 10.1186/s12879-026-12987-3.
- Individual participant dataSharing planned: No
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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.
Cheng Yao, M.D. study director
Frontier Biotechnologies Inc.
7 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 Albuvirtide and 3BNC117 Antibody in people with HIV/AIDS, run by Frontier Biotechnologies Inc. at 7 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 20 inclusion and 21 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 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaomei Wang, MBBS, MS (610-888-3658, wangxiaomei@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 ≥0.5 log10 reduction in HIV-1 RNA viral load from baseline (Day 7) to Day 14 as compared to the control period from Day 0 to Day 7. (time frame: Day 14). 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 NCT04560569, which also lists 1 linked publication.
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 29 Sep 2021.