Clinical Trials List
Protocol NumberUBP-A209-HIV
NCT Number(ClinicalTrials.gov Identfier)NCT03743376
2019-03-01 - 2023-10-07
Phase II
Not yet recruiting1
Recruiting4
ICD-10B20
Human immunodeficiency virus [HIV] disease
The HIV Functional Cure Potential of UB-421: A Phase II, Randomized, Open-label, Controlled, 48 Week, Proof of Concept Study, to Evaluate the Safety of UB-421 in Combination With Standard Antiretroviral Therapy (ART) and the Efficacy of HIV Reservoir Reduction as Compared With ART Alone in ART Stabilized HIV-1 Patients
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Trial Applicant
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Sponsor
United BioPharma
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Trial scale
Taiwan Multiple Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
Audit
None
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Audit
None
Co-Principal Investigator
- 張雅婷 Division of Infectious Disease
- Tun-Chieh Chen Division of Infectious Disease
- Chun-Yuan Lee Division of Infectious Disease
- Shang-Yi Lin Division of Infectious Disease
- Chun-Yu Lin Division of Infectious Disease
- Po-Liang Lu Division of Infectious Disease
- Chung-Hao Huang Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
HIV-1 Infection
Objectives
The primary objective of the study is to examine the long-term (48 weeks) safety profile of UB-421 as an add-on antiretroviral treatment (in 2 different dose schedules: 25 mg/kg Q2W [Arm 2] and 25 mg/kg Q4W [Arm 3]) to the standard baseline ART among
treated HIV-1 patients with plasma VL stably suppressed to undetectable
Test Drug
UB-421
Active Ingredient
dB4C7 monoclonal antibody
Dosage Form
injection
Dosage
10 mg/mL
Endpoints
The incidence of Grade 3 or higher drug-related TEAEs that are probably or definitely related to study treatment
Inclution Criteria
1. HIV-1 sero-positive, with documented HIV-1 infection by official, signed, written history
(eg, laboratory report from the study hospital site).
2. Male with body weight ≥ 50 kg or female with body weight ≥ 45 kg, aged 20 years or older.
3. Have been receiving cART, defined as at least 2 NRTIs plus 1 NNRTI, 1 PI, or 1 INSTI
(the ARV booster allowed, eg, Cobicistat or those co-formulated with PI or INSTI), for
3-10 years (inclusive). Well-tolerated current cART regimen, showing no signs of
ART-related toxicity in the past year, and are expected to continue for the next 2 years
using the same ART regimen without contraindications to the underlying health
conditions or concomitant medicines needed for any co-morbidities. The change in
formulation but not in the 3 ARV types (eg, from 3 tablets to 1 single tablet containing
the same 3 ARV drugs, or from 2 tablets of certain ARV drugs to 1 extended-release
tablet per day, or other similar change are allowed) are considered the same ART regimen.
4. The 2 most recent consecutive measurements of CD4+ T cell count ≥ 350 cells/mm3 prior
to Screening Visit (SV) 2; with a CD4+ T cell count ≥ 350 cells/mm3 obtained within 4 weeks prior to or at SV2.
5. HIV-1 plasma RNA level below 50 RNA copies/mL for at least 12 months prior to SV1,
with at least 2 VL measurements within that 12 months. Viral load should also be below
50 RNA copies/mL within 4 weeks prior to or at SV2. Subjects with single episode of
detectable HIV-1 plasma RNA < 400 RNA copies/mL measured 3 months before SV2
will be eligible if ≥ 2 other VL measurements are below 50 RNA copies/mL in the last 12 months of SV2.
6. HIV-1 pvDNA level(s) within 6 months of initiating the first Treatment Visit (TV1)
should be greater than 300 copies/106 CD4+ T cells; the pvDNA detection is to be
arranged with the UBP designated laboratory at SV1.
7. Have more than 3 different alternative options of optimized ART regimen combinations
that are expected to fully suppress subject’s plasma VL to undetectable levels. One
change of ART regimen due to virological failure (VF) earlier than 12 months before the
SV1 is allowed, but the changes or modification due to toxicity, side effects, or
concomitant medicine use are not counted toward the one time. Also after the ART
change, the subject needs to have been maintaining the viral suppression conditions as
described in the Inclusion Criterion #5 above.
8. Laboratory values at SV2 should meet:
a. Absolute neutrophil count ≥ 1.5 × 109 /L;
b. Hemoglobin ≥ 10 g/dL;
c. Platelets ≥ 75 × 109 /L;
d. Serum alanine transaminase (serum glutamic-pyruvic transaminase/alanine
transaminase) ≤ 3.0 × upper limit of normal (ULN);
e. Serum aspartate transaminase (serum glutamic-oxaloacetic transaminase/aspartate
transaminase) ≤ 3.0 × ULN;
f. Bilirubin (total) < 1.5 × ULN unless Gilbert’s disease is present or the subject is
receiving atazanavir in the absence of other evidence of significant liver disease; and
g. Serum creatinine ≤ 1.5 × ULN.
9. Use of adequate birth control by subjects and their sex partners of the biological opposite
sex if of reproductive potential and sexually active. Adequate birth control is defined as
agreement to consistently practice an effective and accepted method of contraception
throughout the duration of the study and for 4 weeks after the last dose of study drug: i)
For females, adequate birth control methods will be defined as: hormonal contraceptives,
intrauterine device or double barrier contraception, i.e., condom + diaphragm, condom or
diaphragm + spermicidal gel or foam; ii) For males adequate birth control methods will
be defined as double barrier contraception, i.e., condom + diaphragm, condom or
diaphragm + spermicidal gel or foam; iii) For females, menopause is defined as one year
without menses; if in question, a follicle-stimulating hormone of >40 U/ml must be
documented. Hysterectomy, bilateral oophorectomy, or bilateral tubal ligation must be
documented, as applicable. Females of childbearing potential must have a negative serum
pregnancy test at SV2. Detailed definitions of “Woman of childbearing potential
(WOCBP)” and more examples of highly effective contraceptive methods are in the Appendix 4.
10. Subjects must sign the informed consent before undergoing any study procedures.
(eg, laboratory report from the study hospital site).
2. Male with body weight ≥ 50 kg or female with body weight ≥ 45 kg, aged 20 years or older.
3. Have been receiving cART, defined as at least 2 NRTIs plus 1 NNRTI, 1 PI, or 1 INSTI
(the ARV booster allowed, eg, Cobicistat or those co-formulated with PI or INSTI), for
3-10 years (inclusive). Well-tolerated current cART regimen, showing no signs of
ART-related toxicity in the past year, and are expected to continue for the next 2 years
using the same ART regimen without contraindications to the underlying health
conditions or concomitant medicines needed for any co-morbidities. The change in
formulation but not in the 3 ARV types (eg, from 3 tablets to 1 single tablet containing
the same 3 ARV drugs, or from 2 tablets of certain ARV drugs to 1 extended-release
tablet per day, or other similar change are allowed) are considered the same ART regimen.
4. The 2 most recent consecutive measurements of CD4+ T cell count ≥ 350 cells/mm3 prior
to Screening Visit (SV) 2; with a CD4+ T cell count ≥ 350 cells/mm3 obtained within 4 weeks prior to or at SV2.
5. HIV-1 plasma RNA level below 50 RNA copies/mL for at least 12 months prior to SV1,
with at least 2 VL measurements within that 12 months. Viral load should also be below
50 RNA copies/mL within 4 weeks prior to or at SV2. Subjects with single episode of
detectable HIV-1 plasma RNA < 400 RNA copies/mL measured 3 months before SV2
will be eligible if ≥ 2 other VL measurements are below 50 RNA copies/mL in the last 12 months of SV2.
6. HIV-1 pvDNA level(s) within 6 months of initiating the first Treatment Visit (TV1)
should be greater than 300 copies/106 CD4+ T cells; the pvDNA detection is to be
arranged with the UBP designated laboratory at SV1.
7. Have more than 3 different alternative options of optimized ART regimen combinations
that are expected to fully suppress subject’s plasma VL to undetectable levels. One
change of ART regimen due to virological failure (VF) earlier than 12 months before the
SV1 is allowed, but the changes or modification due to toxicity, side effects, or
concomitant medicine use are not counted toward the one time. Also after the ART
change, the subject needs to have been maintaining the viral suppression conditions as
described in the Inclusion Criterion #5 above.
8. Laboratory values at SV2 should meet:
a. Absolute neutrophil count ≥ 1.5 × 109 /L;
b. Hemoglobin ≥ 10 g/dL;
c. Platelets ≥ 75 × 109 /L;
d. Serum alanine transaminase (serum glutamic-pyruvic transaminase/alanine
transaminase) ≤ 3.0 × upper limit of normal (ULN);
e. Serum aspartate transaminase (serum glutamic-oxaloacetic transaminase/aspartate
transaminase) ≤ 3.0 × ULN;
f. Bilirubin (total) < 1.5 × ULN unless Gilbert’s disease is present or the subject is
receiving atazanavir in the absence of other evidence of significant liver disease; and
g. Serum creatinine ≤ 1.5 × ULN.
9. Use of adequate birth control by subjects and their sex partners of the biological opposite
sex if of reproductive potential and sexually active. Adequate birth control is defined as
agreement to consistently practice an effective and accepted method of contraception
throughout the duration of the study and for 4 weeks after the last dose of study drug: i)
For females, adequate birth control methods will be defined as: hormonal contraceptives,
intrauterine device or double barrier contraception, i.e., condom + diaphragm, condom or
diaphragm + spermicidal gel or foam; ii) For males adequate birth control methods will
be defined as double barrier contraception, i.e., condom + diaphragm, condom or
diaphragm + spermicidal gel or foam; iii) For females, menopause is defined as one year
without menses; if in question, a follicle-stimulating hormone of >40 U/ml must be
documented. Hysterectomy, bilateral oophorectomy, or bilateral tubal ligation must be
documented, as applicable. Females of childbearing potential must have a negative serum
pregnancy test at SV2. Detailed definitions of “Woman of childbearing potential
(WOCBP)” and more examples of highly effective contraceptive methods are in the Appendix 4.
10. Subjects must sign the informed consent before undergoing any study procedures.
Exclusion Criteria
1. Subjects with active systemic infections, except for HIV-1, that the Investigator feels the
infections may confound evaluation and treatment for HIV-1.
2. Any acquired AIDS-defining illness such as non-Hodgkin’s lymphoma or Kaposi’s
sarcoma according to the US Centers for Disease Control and Prevention Classification
System for HIV-1 Infection within the past 12 months before SV2.
3. Any documented CD4+ T cell count < 200 cells/mm3 within the past 12 months before SV2.
4. Any previous exposure to a mAb within 12 weeks prior to the first dose of IP.
5. Any significant diseases (other than HIV-1 infection) or clinically significant findings,
including psychiatric and behavioral problems, determined from screening, medical
history, and/or physical examination that, in the Investigator’s opinion, would preclude
the subject from participating in this study.
6. Current active hepatitis B carriers, ie, hepatitis B surface antigen positive.
7. Current active hepatitis C carriers, ie, hepatitis C virus (HCV) antibody positive.
8. History of anaphylaxis to other mAbs.
9. Any vaccination within 8 weeks prior to the first dose of assigned drug.
10. Use of immunomodulators (including interleukins (ILs), interferon (IFN), cyclosporine,
continual use of systemic corticosteroid for more than 30 days), HIV vaccine, or systemic
chemotherapy within 180 days prior to the first dose of assigned drug.
11. Life expectancy less than 12 months.
12. Any alcohol or illicit drug use, according to the Investigator’s opinion, will interfere with
the subject’s ability to comply with the dosing, visit schedules and protocol evaluations.
13. More than one change of ART regimen because of the inability to achieve or maintain
suppression of viral replication to an HIV-1 RNA level < 200 copies/mL within the past 12 months before SV1.
14. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study.
15. Receipt of any other investigational study agent(s) within 90 days before SV2.
infections may confound evaluation and treatment for HIV-1.
2. Any acquired AIDS-defining illness such as non-Hodgkin’s lymphoma or Kaposi’s
sarcoma according to the US Centers for Disease Control and Prevention Classification
System for HIV-1 Infection within the past 12 months before SV2.
3. Any documented CD4+ T cell count < 200 cells/mm3 within the past 12 months before SV2.
4. Any previous exposure to a mAb within 12 weeks prior to the first dose of IP.
5. Any significant diseases (other than HIV-1 infection) or clinically significant findings,
including psychiatric and behavioral problems, determined from screening, medical
history, and/or physical examination that, in the Investigator’s opinion, would preclude
the subject from participating in this study.
6. Current active hepatitis B carriers, ie, hepatitis B surface antigen positive.
7. Current active hepatitis C carriers, ie, hepatitis C virus (HCV) antibody positive.
8. History of anaphylaxis to other mAbs.
9. Any vaccination within 8 weeks prior to the first dose of assigned drug.
10. Use of immunomodulators (including interleukins (ILs), interferon (IFN), cyclosporine,
continual use of systemic corticosteroid for more than 30 days), HIV vaccine, or systemic
chemotherapy within 180 days prior to the first dose of assigned drug.
11. Life expectancy less than 12 months.
12. Any alcohol or illicit drug use, according to the Investigator’s opinion, will interfere with
the subject’s ability to comply with the dosing, visit schedules and protocol evaluations.
13. More than one change of ART regimen because of the inability to achieve or maintain
suppression of viral replication to an HIV-1 RNA level < 200 copies/mL within the past 12 months before SV1.
14. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study.
15. Receipt of any other investigational study agent(s) within 90 days before SV2.
The Estimated Number of Participants
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Taiwan
39 participants
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Global
39 participants
