Albuvirtide and 3BNC117 as Long-Acting Maintenance Therapy in Virologically Suppressed Subjects

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is an adaptive, phase 2, multicenter, three-part study to establish the dosage, safety and antiviral activity of combination therapy with albuvirtide (ABT) and 3BNC117 as long-acting maintenance therapy in virologically suppressed subjects with HIV-1 infection.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Frontier Biotechnologies Inc.
• Treatments: Antibodies

Criteria

Inclusion Criteria:

• Potential subjects are required to meet all of the following criteria for enrollment into the study.

1. HIV-1 seropositive;

2. Males and females, age ≥18 years;

3. Receiving oral combination antiretroviral therapy for last 24 weeks;

4. No change in antiretroviral regimen within last 4 weeks prior to Screening Visit and in-between Screening Visit and First Treatment Visit with an exception that subjects on NNRTI-containing regimens will be allowed to switch to protease inhibitor- or integrase strand transferase inhibitor-based regimens and such change, if needed, should occur at least 4 weeks prior to cessation of oral antiretroviral therapy;

5. Subject has two or more potential alternative antiretroviral drug options available;

6. Plasma HIV-1 RNA <50 copies/mL at Screening Visit as determined by Human Immunodeficiency Virus 1 (HIV-1) Quantitative, RNA (Taqman® Real-Time PCR);

7. No documented detectable viral loads (HIV-1 RNA > 50 copies/mL) within the last 24 weeks prior to Screening Visit. An exception for a recorded HIV-1 RNA "blip" (e.g., transient HIV-1 RNA <400 copies/mL) can be considered, although the preceding and following HIV-1 RNA measurements should be <50 copies/mL;

8. CD4 cell count of >300 cells/mm3 at Screening Visit;

9. Laboratory values at Screening:

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 ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator;

11. Both male and female subjects 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 or who do not have sex with women). 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;

12. Willing and able to participate in all aspects of the study, including use of intravenous 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, psychologic, 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:

• Potential subjects meeting any of the following criteria will be excluded from enrollment.

1. Any active infection or malignancy requiring acute therapy;

2. Hepatitis B infection as manifest by the presence of Hepatitis B surface antigen (HBsAg);

3. Hepatitis C infection as manifest by positive anti-HCV antibody and positive HCV RNA assay at the time of screening;

4. Grade 4 DAIDS laboratory abnormality;

5. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study;

6. Unexplained fever or clinically significant illness within 1 week prior to the first study dose;

7. Any vaccination within 2 weeks prior to the first study dose;

8. Subjects weighing <35kg;

9. History of anaphylaxis to any oral or parenteral drugs;

10. Use of any fusion inhibitors and broadly neutralizing monoclonal antibody prior to the Screening Visit;

11. Participation in an experimental drug trial(s) within 30 days of the Screening Visit;

12. Any known allergy or antibodies to the study drug or excipients;

13. 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.

14. Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.