HIV-1 Infection in Adults (Asymptomatic)Phase 1NCT01140126

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

A Phase 1 study testing Antibody UB-421 in people with HIV-1 Infection in Adults (Asymptomatic), 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

Search all trials

Trial summary

Who is it for?: Ages 20 years and older
Conditions the study is for: HIV-1 Infection in Adults (Asymptomatic)
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: 20 participants
Where: 2 sitesTaiwan
Study dates: May 2010to Jul 2011
Phase: Phase 1
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)
Prior participation in any HIV vaccine trial
Previous exposure to a monoclonal antibody
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 I, Open-label, Single-dose, Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of the UB-421 Antibody in Asymptomatic HIV-1 Infected Adults

The purpose of this Phase I study is to determine whether the antibody (UB-421), targeting the HIV-1 receptor on the CD4 molecule (domain 1) of T-lymphocytes and monocytes, is safe and well tolerated when administered to asymptomatic HIV-1 infected adults by intravenous infusion 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.

Conditions: HIV-1 Infection in Adults (Asymptomatic)
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
Single intravenous infusion at day 0 of a liquid dose of 1, 5, 10 or 25 mg/kg body weight.

Study groups in NCT01140126
Study group	Role	What they receive
Antibody (UB-421)	Experimental	Not described Receives: Drug: Antibody UB-421

What is being measured

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

To evaluate safety and tolerability of a single intravenous infusion at escalating doses of UB-421.
Measured: Screen, treatment & follow-up: 62 to 90 days

Secondary outcomes (1)

To determine pharmacokinetic parameters of a single intravenous infusion at escalating doses of UB-421.
Measured: Screen, treatment & follow-up: 62 to 90 days

Timeline

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

May 2010Jul 2011

First posted9 Jun 2010 (estimated)
Study startMay 2010
Primary completionJul 2011
Study completionJul 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HIV-1 Infection in Adults (Asymptomatic)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01140126
Sponsor's protocol ID: UBI Protocol A101
Other IDs: Protocol A101-HIV
Status last verified: Jul 2011
First submitted: 7 Jun 2010
Last updated: 11 Jul 2011
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

Study at a glance

From the registry record, last updated by the sponsor on 11 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Open-label, Single-dose, Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of the UB-421 Antibody in Asymptomatic HIV-1 Infected Adults
ClinicalTrials.gov ID: NCT01140126
Acronym / sponsor ID: UBI Protocol A101
Conditions: HIV-1 Infection in Adults (Asymptomatic)
Keywords: HIV-1, CD4, antibody, immunotherapy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: United BiomedicalIndustry (pharma, biotech, devices)
Study start: May 2010
Primary completion: Jul 2011 (actual)
Study completion: Jul 2011 (actual)
First posted: 9 Jun 2010 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Antibody (UB-421)	Experimental	Drug: Antibody UB-421

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Antibody UB-421Single intravenous infusion at day 0 of a liquid dose of 1, 5, 10 or 25 mg/kg body weight.	Drug	Antibody (UB-421)

Primary outcome

To evaluate safety and tolerability of a single intravenous infusion at escalating doses of UB-421.
Time frame: Screen, treatment & follow-up: 62 to 90 days

1 secondary outcome

To determine pharmacokinetic parameters of a single intravenous infusion at escalating doses of UB-421.
Time frame: Screen, treatment & follow-up: 62 to 90 days

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2011.
Background: PubMed 10468614Wang 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Wing Wai Wong, M.D. principal investigator

Taipei Veterans General Hospital (TVGH), Taiwan

Hung Chin Tsai, M.D. principal investigator

Kaohsiung Veterans General Hospital (KVGH), Taiwan

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Antibody UB-421 in people with HIV-1 Infection in Adults (Asymptomatic), 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 11 Jul 2011. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 a single intravenous infusion at escalating doses of UB-421. (time frame: Screen, treatment & follow-up: 62 to 90 days). 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 NCT01140126, which also lists 1 linked publication.

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 11 Jul 2011.