HIV InfectionsPhase 1NCT00114699

Safety and Efficacy of an Antibody to CCR5 in Individuals With HIV Who Are Not Currently on Antiretroviral Therapy

A Phase 1 study testing CCR5mAb004 in people with HIV Infections, run by Human Genome Sciences Inc. at 7 sites in United States.

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

Who is it for?: Ages 18 to 64 years
Conditions the study is for: HIV Infections
What is being tested?: CCR5mAb004
How many people: 40 participants
Where: 7 sitesUnited States
Study dates: Apr 2005to Apr 2006
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 18 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

HIV-1 infection confirmed by enzyme immunoassay (EIA) and Western blot.
Age 18 to 64 years.
HIV-1 RNA > 5000 copies/mL.
CD4+ T cell count > 250 cells/uL.
Treatment naïve, or off antiretroviral treatment for at least 30 days prior to screening and 60 days prior to Day 0
CCR5 tropism confirmed by R5 PhenoSense assays.

Who cannot join

CXCR4 tropic or dual tropic virus at screening.
Laboratory values of Grade 3 or greater according to the Modified Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Tables.
History of Category C AIDS-defining illness according to the 1993 Centers for Disease Control and Prevention (CDC) AIDS surveillance definition.
History of any medical disease or condition that makes the subject (in the opinion of the investigator) unsuitable for the study.
Malignancy within the past 5 years (except for basal carcinomas of the skin and in situ cancers of the cervix).
Females who are pregnant or breastfeeding, or who plan to become pregnant during the study.

Show all 9Show fewer

Subjects whose dosage or number of prescription medications has changed within 30 days prior to screening
Positive for hepatitis B surface antigen (HBsAg) or antibody to hepatitis C virus (HCV).
Positive alcohol or drug screen

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Johns Hopkins Hospital
Baltimore, Maryland
University Hospitals of Cleveland
Cleveland, Ohio
OSU Medical Center
Columbus, Ohio
Study site
Fort Lauderdale, Florida
AIDS Research Alliance
Los Angeles, California
The Orlando Immunology Center
Orlando, Florida
Quest Clinical Research
San Francisco, California

Other trials in United States

About this study

Official title: A Phase 1, Randomized, Placebo-Controlled, Single-Injection, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ccr5mab004 (Human Monoclonal Igg4 Antibody To Ccr5) in Hiv-1 Seropositive Individuals Who Are Not Receiving Concurrent Antiretroviral Therapy

This is a phase 1, randomized, placebo-controlled, dose-escalation study of CCR5mAb004 in HIV-1 seropositive individuals who are not receiving concurrent antiretroviral therapy. Subjects will be randomly assigned to receive a single intravenous (IV) infusion of one of four dose levels of CCR5mAb004 or matching placebo. A minimum of 10 subjects will be randomized to each cohort at a ratio of 4:1 (active:placebo). A minimum of 40 and maximum of 60 subjects will be enrolled. This study will be conducted at up to 10 sites in the United States.

Subjects in each cohort will be followed for 56 days after study agent administration. The safety, tolerability, and immunogenicity of CCR5mAb004 will be evaluated based on physical examination, adverse event (AE) reporting, and clinical laboratory tests. Blood will be collected at specified times for the determination of CCR5mAb004 serum concentrations, HIV-1 RNA levels, and CD4+ and CD8+ cell counts. If CD4+ cell counts are less than 200 during the study period, the subject should be offered standard-of-care per HIV treatment guidelines that may include the initiation of appropriate anti-retroviral therapy (AVR). CCR5mAb004 pharmacokinetic (PK) and pharmacodynamics (PD) will be measured over the 56-day study period. Anti-CCR5mAb004 antibody titers will be assessed prior to dosing on Day 0 and on Day 28 and Day 56.

Conditions: HIV Infections
Being tested: CCR5mAb004
Keywords: HIV, Treatment Naive
Medical subject headings: HIV Infections

What participants receive

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

CCR5mAb004Drug

What is being measured

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

The major safety endpoints are AE rates and laboratory abnormalities through Day 56.

Secondary outcomes (1)

The efficacy endpoints include change from baseline HIV-1 RNA levels (including viral kinetics) through Day 56, and change from baseline CD4+ and CD8+ cell counts through Day 56.

Timeline

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

Apr 2005Apr 2006

First posted17 Jun 2005 (estimated)
Study startApr 2005
Study completionApr 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HIV InfectionsStudies 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: Randomised
Intervention model: Single group
Masking: Single blind
Enrolment: 40 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00114699
Sponsor's protocol ID: CCR5-HV01
Status last verified: Aug 2013
First submitted: 16 Jun 2005
Last updated: 2 Aug 2013
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Placebo-Controlled, Single-Injection, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ccr5mab004 (Human Monoclonal Igg4 Antibody To Ccr5) in Hiv-1 Seropositive Individuals Who Are Not Receiving Concurrent Antiretroviral Therapy
ClinicalTrials.gov ID: NCT00114699
Acronym / sponsor ID: CCR5-HV01
Conditions: HIV Infections
Keywords: HIV, Treatment Naive
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants
Lead sponsor: Human Genome Sciences Inc.Industry (pharma, biotech, devices)
Study start: Apr 2005
Study completion: Apr 2006 (actual)
First posted: 17 Jun 2005 (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: Randomised
Intervention model: Single group
Masking: Single blind

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

HIV-1 infection confirmed by enzyme immunoassay (EIA) and Western blot.
Age 18 to 64 years.
HIV-1 RNA > 5000 copies/mL.
CD4+ T cell count > 250 cells/uL.
Treatment naïve, or off antiretroviral treatment for at least 30 days prior to screening and 60 days prior to Day 0

Key exclusion criteria (9 listed)

CXCR4 tropic or dual tropic virus at screening.
Laboratory values of Grade 3 or greater according to the Modified Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Tables.
History of Category C AIDS-defining illness according to the 1993 Centers for Disease Control and Prevention (CDC) AIDS surveillance definition.
History of any medical disease or condition that makes the subject (in the opinion of the investigator) unsuitable for the study.
Malignancy within the past 5 years (except for basal carcinomas of the skin and in situ cancers of the cervix).

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
CCR5mAb004	Drug	–

Primary outcome

The major safety endpoints are AE rates and laboratory abnormalities through Day 56.

1 secondary outcome

The efficacy endpoints include change from baseline HIV-1 RNA levels (including viral kinetics) through Day 56, and change from baseline CD4+ and CD8+ cell counts through Day 56.

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 2 Aug 2013.

Related trials for HIV Infections

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Not yet recruiting
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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.

GSK Clinical Trials study director

GlaxoSmithKline

7 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 CCR5mAb004 in people with HIV Infections, run by Human Genome Sciences Inc. at 7 sites in United States.

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 6 inclusion and 9 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 2 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. 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?

The major safety endpoints are AE rates and laboratory abnormalities through Day 56.. 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 NCT00114699.

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 2 Aug 2013.