Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04560569
Other study ID # ABT-3BNC117_203
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date November 30, 2021
Est. completion date December 1, 2022

Study information

Verified date January 2021
Source Frontier Biotechnologies Inc.
Contact Xiaomei Wang, MBBS, MS
Phone 610-888-3658
Email wangxiaomei@frontierbiotech.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date December 1, 2022
Est. primary completion date November 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Albuvirtide
Long-Acting HIV-1 Fusion Inhibitor (chemically modified peptide targeting HIV-1 gp41)
3BNC117 Antibody
Recombinant, fully human mAb of the IgG1? isotype that specifically binds to HIV-1 gp120

Locations

Country Name City State
United States ABT-3BNC117_203 Investigational Site Canoga Park California
United States ABT-3BNC117_203 Investigational Site Decatur Georgia
United States ABT-3BNC117_203 Investigational Site Hialeah Florida
United States ABT-3BNC117_203 Investigational Site Orlando Florida
United States ABT-3BNC117_203 Investigational Site Saint Louis Missouri
United States ABT-3BNC117_203 Investigational Site San Francisco California
United States ABT-3BNC117_203 Investigational Site West Palm Beach Florida

Sponsors (1)

Lead Sponsor Collaborator
Frontier Biotechnologies Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) Day 14
Secondary 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 Day 14
Secondary 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 Day 14
Secondary Percentage of participants achieving HIV-1 RNA <200 copies/mL at the EOT. Percentage of participants achieving HIV-1 RNA <200 copies/mL Week 25/EOT
Secondary 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 Through Week 25/EOT
Secondary 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 Week 25/EOT
Secondary 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 Week 25/EOT
See also
  Status Clinical Trial Phase
Completed NCT03413696 - Effects of Health Literacy and HCV Knowledge on HCV Treatment Willingness in HIV-coinfected Patients
Completed NCT03289676 - Storytelling Narrative Communication Intervention for Smoking Cessation in Women Living With HIV Phase 1
Completed NCT03215901 - Life Plans Intervention Study N/A
Completed NCT03268551 - MEMO-Medical Marijuana and Opioids Study
Active, not recruiting NCT04064567 - Linking High-Risk Jail Detainees to HIV Pre-Exposure Prophylaxis: PrEP-LINK N/A
Completed NCT04121962 - A Pilot Peer Mentor Intervention That Trains Black Men Who Have Sex With Men (BMSM) to Use and Promote Uptake of HIV/STI Self-Testing to Peers and Sex Partners: STAR Study (Self-Testing at Your Residence) N/A
Completed NCT04013295 - Prize-linked Savings Initiatives for Promoting Better Health and Economic Outcomes in Kenya N/A
Recruiting NCT04405700 - Measuring Adverse Pregnancy and Newborn Congenital Outcomes
Recruiting NCT03984136 - HIV Results Exchange Mechanism on Promoting HIV Testing Among MSM N/A
Completed NCT02928900 - Patient Actor Training to Improve HIV Services for Adolescents in Kenya N/A
Recruiting NCT03268109 - COGnitive ImpairmenT in Older HIV-infected Patients ≥ 65 Years Old
Not yet recruiting NCT05813964 - Efficacy, Acceptability and Safety of Event-driven HIV PrEP Using TAF/FTC in MSM in Thailand and France. Phase 3
Completed NCT02797262 - Measuring and Monitoring Adherence to ART With Pill Ingestible Sensor System N/A
Completed NCT02376582 - Safety and Immunogenicity Study of a DNA Vaccine Combined With Protein Vaccine Against HIV/AIDS Phase 1
Completed NCT01957865 - Real-Time Antiretroviral Therapy Adherence Intervention in Uganda N/A
Completed NCT01616940 - Minority AIDS Initiative Retention and Re-Engagement Project N/A
Terminated NCT01443923 - Boceprevir Drug Combination for Hepatitis C Treatment in People With and Without HIV Phase 4
Completed NCT01910714 - Adapting and Evaluating an EBI to Prevent HIV/AIDS Risk Among Apache Youth N/A
Completed NCT01084421 - A Computer-Based Parent/Adolescent HIV Communication Intervention for Latinos N/A
Completed NCT01596322 - International HIV Antiretroviral Adherence, Resistance and Survival N/A