HIV InfectionsPhase 1NCT00917813
A Study of Anti-HIV Monoclonal Antibody KD-247
A Phase 1 study testing KD-247 and Physiological saline in people with HIV Infections, run by The Chemo-Sero-Therapeutic Research Institute at 15 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of 3 infusions of KD-247 over 2 weeks in HIV-1 seropositive individuals; to determine the pharmacokinetic parameters of KD-247 when administered as above; and to assess the effect of KD-247 infusions on plasma HIV-1 ribonucleic acid (RNA) load and on… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- KD-247 and Physiological saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 15 sitesUnited States
- Study dates
- Sep 2007to not given
- 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
- Have HIV-1 infection confirmed by enzyme immunoassay (EIA) and immunoblot.
- Are male or female subjects, age 18-64 years.
- Demonstrate an HIV-1 RNA copy number between 1000 and 100,000 copies/mL on 2 measurements at least 2 weeks apart. Measurements taken during screening and/or on a prior non-study related medical visit within 3 to 6 weeks of Study Day 1 may be considered.
- Have CD4+ T cell count >350 cells/mm3 on 2 measurements at least 2 weeks apart. Measurements taken during screening and on one prior non-study medical visit within 3 to 6 weeks of Study Day 1 may be considered.
- Are treatment naïve or have been off antiretroviral drugs for at least 8 weeks prior to screening.
- By genotyping, have a sequence of the portion of the HIV envelope gene encoding the principal neutralizing determinant that is consistent with neutralization by KD-247.
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- Weigh 45-120 kg.
- Have an absolute neutrophil count >1000 cells/uL, hemoglobin (Hgb) >10 g/dL, and platelets >100,000/uL.
- Have serum creatinine ≤1.5 mg/dL and alanine transaminase (ALT) <2.5 times the upper limit of normal.
- Have a 12-lead electrocardiogram (ECG) without clinically significant abnormalities in the opinion of the investigator.
- Female subjects must be:
- Women of non-childbearing potential, defined as either surgically sterile or at least 1-year post-menopausal (no menstrual periods for at least 2 years), or
- Women of childbearing potential using a highly effective method of contraception, and
- Women of childbearing potential with a negative serum beta human chorionic gonadotropin (β-HCG) test result at screening and within the 24 hours prior to administration of study drug. A negative urine pregnancy test within the 24 hours prior to administration of study drug will be acceptable, if the serum pregnancy test result is not yet available.
- For heterosexual male subjects, the subject and the subject's sexual partner must agree to use acceptable methods of contraception during the entire study. Acceptable methods include, but are not limited to, intrauterine device, diaphragm with spermicide, condoms, or abstinence. Oral contraceptives alone are not an acceptable method of birth control.
- Be willing and able to provide written informed consent.
Who cannot join
- Have a history of an acquired immune deficiency syndrome (AIDS)-defining illness or symptomatic HIV disease (i.e., Centers for Disease Control [CDC] Class B or C).
- Have received monoclonal antibody therapy of any kind in the past.
- Received vaccinations in the past 15 days prior to study entry.
- Received antihistamines in the 6 weeks prior to study entry.
- Received non-steroidal anti-inflammatory drugs (NSAIDs) in the 5-6 days prior to skin test.
- Any history of anaphylaxis, asthma, hypersensitivity reaction to a vaccine or drug infusion, angioedema, or urticaria.
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- Have been treated with any of the following within the 3 months prior to screening: interferons, cytokines, or other immunomodulators; immunoglobulin therapy; systemic corticosteroids; cytotoxic drugs; or ionizing radiation.
- Have received any investigational agent within 60 days prior to screening.
- Have any condition which, in the judgment of the investigator, may make the subject's participation in this study too risky; interfere with the collection of or interpretation of PK data; or interfere with the ability of the subject to adhere to and complete the study. Such conditions may include, but are not limited to, cardiovascular, respiratory, gastrointestinal/hepatic, neurologic, and genitourinary disorders.
- Current alcohol or drug use that, in the judgment of the investigator, will interfere with the subject's ability to comply with the protocol requirements.
- Have an unexplained positive urine drug screen test for an illicit drug.
- Have a confirmed positive hepatitis B surface antigen (HBsAg) or antibody to hepatitis C virus (HCV).
- Have used any prescription within 14 days of study initiation or any over-the-counter (OTC) medication within 3 days of study initiation which, in the judgment of the investigator, would place the individual at risk or interfere with safety, tolerability, or PK data.
- Have dosages/amounts of drugs that have changed, or are scheduled to use new drugs which, in the judgment of the investigator, would place the individual at risk or interfere with safety, tolerability, or PK data.
- Have a recent history of major surgery, internal organ biopsy, or major trauma.
- Females who are pregnant or breast-feeding, or who plan to become pregnant during the study.
- Have a mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- Show a positive reaction to the prick test for KD-247, i.e., ≥3 mm in diameter greater than the negative control.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Albany Medical Center
Albany, New York, 12208
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
Central Texas Clinical Research
Austin, Texas, 78705
Institute of Human Virology, University of Maryland
Baltimore, Maryland, 21201
Pacific Oaks Medical Group
Beverly Hills, California, 90211
Providence Clinical Research
Burbank, California, 91505
Northstar Medical
Chicago, Illinois, 60657
Gary Richmond, MD, PA
Fort Lauderdale, Florida, 33316
Therapeutic Concepts, P.A.
Houston, Texas, 77004
DCOL Center for Clinical Research
Longview, Texas, 75605
Peter J. Ruane, MD, Inc.
Los Angeles, California, 90036
Aaron Diamond AIDS Research Center (ADARC)
New York, New York, 10016
Orlando Immunology Center
Orlando, Florida, 32803-1851
Vita Research Solutions, Inc.
Tamarac, Florida, 33319
Washington Hospital Center CAR
Washington D.C., District of Columbia, 20010
About this study
Official title: A Study of the Safety, Tolerability, and Pharmacokinetics of KD-247, a Humanized Monoclonal Antibody That Recognizes the Principal Neutralizing Determinant of HIV-1, in Asymptomatic HIV-1 Seropositive Individuals Who Are Not Receiving Concurrent Antiretroviral Therapy
The purpose of this study is to evaluate the safety and tolerability of 3 infusions of KD-247 over 2 weeks in HIV-1 seropositive individuals; to determine the pharmacokinetic parameters of KD-247 when administered as above; and to assess the effect of KD-247 infusions on plasma HIV-1 ribonucleic acid (RNA) load and on CD4+ T cell counts.
Read the detailed description
A minimum of 6 active subjects and 3 placebo subjects for each dose cohort will complete 2 weeks of infusions. A maximum of 27 total subjects will be dosed with KD-247 and up to 9 total will receive placebo. Per cohort subjects randomized to active treatment will receive iv infusions of KD 247 over 2 hours at each dosing visit. Subjects randomized to placebo will receive 2-hour iv infusions of saline solution at each dosing visit. Following the first infusion of KD-247 (or placebo) for each subject in the study, there will be a 24-hour in-patient observation period before the next subject can be randomized within the study. Dose escalation will proceed only after safety data through Day 18 for all subjects in the lower-dose cohort is reviewed.
- Conditions
- HIV Infections
- Being tested
- KD-247, Physiological saline
- Keywords
- HIV, monoclonal antibody, KD-247, 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.
KD-247Drug
Cohort 1 - 4 mg/kg KD-247 IV on Days 1, 8, and 15; Cohort 2 - 8 mg/kg KD-247 IV on Days 1, 8, and 15; Cohort 3 - 16 mg/kg KD-247 IV on Days 1, 8, and 15
Physiological salineDrug
Cohort 1 - Physiological saline IV on Days 1, 8, and 15; Cohort 2 - Physiological saline IV on Days 1, 8, and 15; Cohort 3 - Physiological saline IV on Days 1, 8, and 15
| Study group | Role | What they receive |
|---|---|---|
| KD-247 | Experimental | Not described Receives: Drug: KD-247 |
| Placebo | Placebo comparator | Not described Receives: Drug: Physiological saline |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
- Study startSep 2007
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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Chemo-Sero-Therapeutic Research Institute
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00917813
- Sponsor's protocol ID
- KD-1002
- Status last verified
- Nov 2012
- First submitted
- 8 Jun 2009
- Last updated
- 19 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Safety, Tolerability, and Pharmacokinetics of KD-247, a Humanized Monoclonal Antibody That Recognizes the Principal Neutralizing Determinant of HIV-1, in Asymptomatic HIV-1 Seropositive Individuals Who Are Not Receiving Concurrent Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT00917813
- Acronym / sponsor ID
- KD-1002
- Conditions
- HIV Infections
- Keywords
- HIV, monoclonal antibody, KD-247, treatment naive
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- The Chemo-Sero-Therapeutic Research InstituteIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- First posted
- 10 Jun 2009 (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.
The purpose of this study is to evaluate the safety and tolerability of 3 infusions of KD-247 over 2 weeks in HIV-1 seropositive individuals; to determine the pharmacokinetic parameters of KD-247 when administered as above; and to assess the effect of KD-247 infusions on plasma HIV-1 ribonucleic acid (RNA) load and on CD4+ T cell counts.
Detailed description
A minimum of 6 active subjects and 3 placebo subjects for each dose cohort will complete 2 weeks of infusions. A maximum of 27 total subjects will be dosed with KD-247 and up to 9 total will receive placebo. Per cohort subjects randomized to active treatment will receive iv infusions of KD 247 over 2 hours at each dosing visit. Subjects randomized to placebo will receive 2-hour iv infusions of saline solution at each dosing visit. Following the first infusion of KD-247 (or placebo) for each subject in the study, there will be a 24-hour in-patient observation period before the next subject can be randomized within the study. Dose escalation will proceed only after safety data through Day 18 for all subjects in the lower-dose cohort is reviewed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KD-247 | Experimental | Drug: KD-247 |
| Placebo | Placebo comparator | Drug: Physiological saline |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Have HIV-1 infection confirmed by enzyme immunoassay (EIA) and immunoblot.
- Are male or female subjects, age 18-64 years.
- Demonstrate an HIV-1 RNA copy number between 1000 and 100,000 copies/mL on 2 measurements at least 2 weeks apart. Measurements taken during screening and/or on a prior non-study related medical visit within 3 to 6 weeks of Study Day 1 may be considered.
- Have CD4+ T cell count >350 cells/mm3 on 2 measurements at least 2 weeks apart. Measurements taken during screening and on one prior non-study medical visit within 3 to 6 weeks of Study Day 1 may be considered.
- Are treatment naïve or have been off antiretroviral drugs for at least 8 weeks prior to screening.
Key exclusion criteria (18 listed)
- Have a history of an acquired immune deficiency syndrome (AIDS)-defining illness or symptomatic HIV disease (i.e., Centers for Disease Control [CDC] Class B or C).
- Have received monoclonal antibody therapy of any kind in the past.
- Received vaccinations in the past 15 days prior to study entry.
- Received antihistamines in the 6 weeks prior to study entry.
- Received non-steroidal anti-inflammatory drugs (NSAIDs) in the 5-6 days prior to skin test.
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 |
|---|---|---|
| KD-247Cohort 1 - 4 mg/kg KD-247 IV on Days 1, 8, and 15; Cohort 2 - 8 mg/kg KD-247 IV on Days 1, 8, and 15; Cohort 3 - 16 mg/kg KD-247 IV on Days 1, 8, and 15 | Drug | KD-247 |
| Physiological salineCohort 1 - Physiological saline IV on Days 1, 8, and 15; Cohort 2 - Physiological saline IV on Days 1, 8, and 15; Cohort 3 - Physiological saline IV on Days 1, 8, and 15 | Drug | Placebo |
Primary outcome
Not reported in the source record.
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 19 Nov 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
15 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 KD-247 and Physiological saline in people with HIV Infections, run by The Chemo-Sero-Therapeutic Research Institute at 15 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 16 inclusion and 18 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 19 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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. Some participants in this study may receive a placebo. 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.
Where can I read the original study information?
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 19 Nov 2012.