- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04560569
Albuvirtide in Combination With 3BNC117 in Patients With Multi-Drug Resistant (MDR) HIV-1 Infection
A Multicenter, Two-Arm, 24-Week Study of Albuvirtide in Combination With 3BNC117 in Patients With Multi-Drug Resistant (MDR) HIV-1 Infection
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Xiaomei Wang, MBBS, MS
- Phone Number: 610-888-3658
- Email: wangxiaomei@frontierbiotech.com
Study Locations
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-
California
-
Canoga Park, California, United States, 91309
- Recruiting
- ABT-3BNC117_203 Investigational Site
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San Francisco, California, United States, 94115
- Recruiting
- ABT-3BNC117_203 Investigational Site
-
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Florida
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Hialeah, Florida, United States, 33016
- Recruiting
- ABT-3BNC117_203 Investigational Site
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Orlando, Florida, United States, 32803
- Recruiting
- ABT-3BNC117_203 Investigational Site
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West Palm Beach, Florida, United States, 33407
- Recruiting
- ABT-3BNC117_203 Investigational Site
-
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Georgia
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Decatur, Georgia, United States, 30030
- Recruiting
- ABT-3BNC117_203 Investigational Site
-
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Missouri
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Saint Louis, Missouri, United States, 63108
- Recruiting
- ABT-3BNC117_203 Investigational Site
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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;
- 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.
Exclusion Criteria:
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;
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Group A
ABT weekly and 3BNC117 bi-weekly
|
Long-Acting HIV-1 Fusion Inhibitor (chemically modified peptide targeting HIV-1 gp41)
Other Names:
Recombinant, fully human mAb of the IgG1κ isotype that specifically binds to HIV-1 gp120
Other Names:
|
EXPERIMENTAL: Group B
both ABT and 3BNC117 treatment bi-weekly
|
Long-Acting HIV-1 Fusion Inhibitor (chemically modified peptide targeting HIV-1 gp41)
Other Names:
Recombinant, fully human mAb of the IgG1κ isotype that specifically binds to HIV-1 gp120
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Day 14
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 HIV-1 RNA levels from Day 7 to Day 14
|
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
|
Mean change in CD4+/CD8+ T cell count from Day 7 to Day 14
|
Day 14
|
Percentage of participants achieving HIV-1 RNA <200 copies/mL at the EOT.
Time Frame: Week 25/EOT
|
Percentage of participants achieving HIV-1 RNA <200 copies/mL
|
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 from Day 0 to EOT
|
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 HIV-1 RNA levels from Day 7 to EOT
|
Week 25/EOT
|
Mean change in CD4+/CD8+ T cell count from baseline (Day 7) to EOT.
Time Frame: Week 25/EOT
|
Mean change in CD4+/CD8+ T cell count from Day 7 to EOT
|
Week 25/EOT
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Cheng Yao, M.D., Frontier Biotechnologies Inc.
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Infections
- Acquired Immunodeficiency Syndrome
- Physiological Effects of Drugs
- Immunologic Factors
- Antibodies
Other Study ID Numbers
- ABT-3BNC117_203
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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