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HIV-1 Infection in AdultsPhase 2NCT01668043

Study to Evaluate Safety and Efficacy of UB-421 Antibody in HIV-1 Infected Adults

A Phase 2 study testing Antibody UB-421 in people with HIV-1 Infection in Adults, run by United Biomedical at 2 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this Phase IIa study is to determine whether the antibody (UB-421), targeting the HIV-1 receptor on the CD4 molecule of T-lymphocytes and monocytes, is safe and effective when multiple doses are administered by intravenous infusion to asymptomatic HIV-1 infected adults and to assess pharmacokinetic… Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
HIV-1 Infection in Adults
What is being tested?
Antibody UB-421
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
2 sitesTaiwan
Study dates
Sep 2012to Mar 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Asymptomatic, treatment-naive, HIV-1 seropositive
  • CD4+ T cell count >350 cells/cubic millimeter
  • HIV-1 viral load >5,000 copies/mL
  • Other inclusion criteria apply

Who cannot join

  • Active infection requiring immediate therapy (except HIV-1)
  • Previous exposure to monoclonal antibody (including UB-421)
  • Prior participation in any HIV vaccine trial
  • Use of immunomodulating drugs or systemic chemotherapy
  • Other exclusion criteria apply

Trial locations and contacts

2 sites in 1 country.

Taiwan2 sites

  • Kaohsiung Veterans General Hospital (KVGH)

    Kaohsiung City, Zuoying District, 81362

  • Taipei Veterans General Hospital (TVGH)

    Taipei, Beitou District, 11217

Other trials in Taiwan

About this study

Official title: A Phase IIa, Open-label, Multiple-Dose Trial to Investigate the Safety and Efficacy of the UB-421 in Asymptomatic HIV-1 Infected Adults

The purpose of this Phase IIa study is to determine whether the antibody (UB-421), targeting the HIV-1 receptor on the CD4 molecule of T-lymphocytes and monocytes, is safe and effective when multiple doses are administered by intravenous infusion to asymptomatic HIV-1 infected adults and to assess pharmacokinetic parameters of the antibody in blood and on cells. The neutralizing activity of UB-421 blocks HIV-1 from binding to its receptor on CD4-positive cells; thus, UB-421 functions as an immunotherapeutic intervention to prevent HIV-1 infection.

Being tested
Antibody UB-421
Keywords
HIV-1, CD4, antibody, immunotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Antibody UB-421Drug

    UB-421 is administered by intravenous infusion

Study groups in NCT01668043
Study groupRoleWhat they receive
Antibody UB-421 Cohort 1Experimental10 mg/kg BW, 8 weekly doses for 8-week treatment period
Receives: Drug: Antibody UB-421
Antibody UB-421 Cohort 2Experimental25 mg/kg BW, 4 biweekly doses for 8-week treatment period
Receives: Drug: Antibody UB-421

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate safety and tolerability of multiple intravenous infusions of two dose cohorts of UB-421

    Safety evaluations include physical examination, measurement of vital signs, clinical chemistry and hematology tests at each visit (to assess changes from normal range), incidence of adverse event (AE) and serious AE (SAE) of two dose cohorts and are followed for 16 weeks (end of study).

    Overall treatment tolerability of UB-421 for each cohort is defined as the percentage of the number of actual infusion doses divided by number of actual infusion doses plus number of missed doses of subject(s) who drops out due to drug-related AE(s); calculation follows specific formula.

    Measured: 16-week study period

  2. To evaluate efficacy by measurement of individual maximal viral load reduction and mean maximal viral load reduction of two dose cohorts of UB-421.

    Efficacy measurements include virologic responses and determination of the proportion of subjects with viral load <50 copies/mL or <200 copies/mL; viral load reduction >0.5 log10 copies/mL or >1.0 log10 copies/mL; viral rebound over 0.5 log10 increase in viral load from the nadir value during 8-week treatment period, suggesting presence of study drug resistance mutants. HIV-1 viral load is determined at each blood collection during 16-week study period.

    Measured: 16-week study period

Secondary outcomes (2)

  1. To determine pharmacokinetic parameters of two dose cohorts of UB-421.

    Pharmacokinetic analyses are calculated at each visit during 8-week treatment period to determine the serum concentration before and after each infusion of UB-421 and during the 8-week follow-up period to determine the clearance of study drug in circulation.

    Measured: 16-week study period

  2. To determine the anti-UB-421 antibody concentration in serum of two dose cohorts of UB-421

    Immunogenicity of the study drug is measured by analytical ELISA test at each visit to determine if the anti-UB-421 antibody concentration is increased above the pre-treatment baseline level.

    Measured: 16-week study period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionMar 2014
  4. Study completionMar 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01668043
Sponsor's protocol ID
UBI Protocol A201
Other IDs
Protocol A201-HIV
Status last verified
Aug 2014
First submitted
1 Aug 2012
Last updated
20 Aug 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Wang CY, Sawyer LS, Murthy KK, Fang X, Walfield AM, Ye J, Wang JJ, Chen PD, Li ML, Salas MT, Shen M, Gauduin MC, Boyle RW, Koup RA, Montefiori DC, Mascola JR, Koff WC, Hanson CV. Postexposure immunoprophylaxis of primary isolates by an antibody to HIV receptor complex. Proc Natl Acad Sci U S A. 1999 Aug 31;96(18):10367-72. doi: 10.1073/pnas.96.18.10367.

    PubMed 10468614

  • Lynn S and Wang CY. Designed deimmunied monoclonal antibodies for protection against HIV exposure and treatment of HIV infection. U.S. Patent No. 7,501,494. http://patft.uspto.gov/netahtml/PTO/srchnum.htm

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Antibody UB-421 in people with HIV-1 Infection in Adults, run by United Biomedical at 2 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate safety and tolerability of multiple intravenous infusions of two dose cohorts of UB-421 (time frame: 16-week study period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01668043, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2014; AzTrials last refreshed its copy on 7 Nov 2026.

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