Recruiting
Phase 2

Albuvirtide & 3BNC117

Sponsor:

Frontier Biotechnologies Inc.

Code:

NCT04560569

Conditions

HIV/AIDS

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Albuvirtide

3BNC117 Antibody

Study Details

Brief 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.

Conditions

HIV/AIDS

Study ID

NCT04560569

Start date

Nov 30, 2021

Status verified date

Jan, 2021

Completion date

Dec 1, 2022

Anticipated

Primary completion date

Nov 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Males and females, age ≥ 18 years;
2. HIV-1 seropositive with documented HIV-1 infection by official, signed, written history (e.g. Laboratory report)
3. 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;
4. 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;
5. 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;
6. 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;
7. 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;
8. Have a life expectancy that is > 9 months;
9. Laboratory values at Screening of:

1. Absolute neutrophil count (ANC) ≥ 750/mm3;
2. Hemoglobin (Hb) ≥ 10.5 gm/dL (male) or ≥ 9.5 gm/dL (female);
3. Platelets ≥ 75,000 /mm3;
4. Serum alanine transaminase (SGPT/ALT) < 1.25 x upper limit of normal (ULN);
5. Serum aspartate transaminase (SGOT/AST) < 1.25 x ULN;
6. Serum total bilirubin within normal range; and
7. Creatinine ≤ 1.5 x ULN.
10. Clinically normal resting 12-lead electrocardiogram (ECG) at the Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator
11. 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
12. 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:

1. 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).
2. Any active infection or malignancy requiring acute therapy;
3. Hepatitis B infection as manifest by the presence of Hepatitis B surface antigen (HBsAg);
4. Hepatitis C infection as manifest by positive anti-HCV antibody and positive HCV RNA assay at the time of screening;
5. Grade 4 DAIDS laboratory abnormality;
6. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study;
7. Unexplained fever or clinically significant illness within 1 week prior to the first study dose;
8. Any vaccination within 2 weeks prior to the first study dose;
9. Prior exposure to albuvirtide or 3BNC117
10. Subjects weighing <35kg;
11. History of anaphylaxis to any oral or parenteral drugs;
12. 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;
13. Participation in an experimental drug trial(s) within 30 days of the Screening Visit;
14. Any known allergy or antibodies to the study drug or excipients;
15. Treatment with any of the following:

1. Radiation or cytotoxic chemotherapy with 30 days prior to the screening visit;
2. Immunosuppressants or immunomodulating agents within 60 days prior to the screening visit; or
3. 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.
16. Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group A

ABT weekly and 3BNC117 bi-weekly

experimental: Group B

both ABT and 3BNC117 treatment bi-weekly

Interventions

Albuvirtide

Long-Acting HIV-1 Fusion Inhibitor (chemically modified peptide targeting HIV-1 gp41)

3BNC117 Antibody

Recombinant, fully human mAb of the IgG1κ isotype that specifically binds to HIV-1 gp120

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 ]

Central Contacts and Locations

Locations

ABT-3BNC117_203 Investigational Site

Recruiting

Canoga Park, California, United States, 91309

ABT-3BNC117_203 Investigational Site

Recruiting

San Francisco, California, United States, 94115

ABT-3BNC117_203 Investigational Site

Recruiting

Hialeah, Florida, United States, 33016

ABT-3BNC117_203 Investigational Site

Recruiting

Orlando, Florida, United States, 32803

ABT-3BNC117_203 Investigational Site

Recruiting

West Palm Beach, Florida, United States, 33407

ABT-3BNC117_203 Investigational Site

Recruiting

Decatur, Georgia, United States, 30030

ABT-3BNC117_203 Investigational Site

Recruiting

Saint Louis, Missouri, United States, 63108

More Information

Sponsor

Frontier Biotechnologies Inc.

Last update posted

Sep 29, 2021

Last verified

Jan, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Frontier Biotechnologies Inc. on 2021-09-29.