A Study of Anti-HIV Monoclonal Antibody KD-247

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00917813
• Date of registration: 08/06/2009
• Primary sponsor: The Chemo-Sero-Therapeutic Research Institute
• Public title: A Study of Anti-HIV Monoclonal Antibody KD-247
• Scientific 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
• Date of first enrolment: September 2007
• Target sample size: 27
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00917813
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

United States

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Have HIV-1 infection confirmed by enzyme immunoassay (EIA) and immunoblot.

2. Are male or female subjects, age 18-64 years.

3. 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.

4. 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.

5. Are treatment naïve or have been off antiretroviral drugs for at least 8 weeks prior
to screening.

6. 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.

7. Weigh 45-120 kg.

8. Have an absolute neutrophil count >1000 cells/uL, hemoglobin (Hgb) >10 g/dL, and
platelets >100,000/uL.

9. Have serum creatinine =1.5 mg/dL and alanine transaminase (ALT) <2.5 times the upper
limit of normal.

10. Have a 12-lead electrocardiogram (ECG) without clinically significant abnormalities
in the opinion of the investigator.

11. 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 (ß-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.

12. 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.

13. Be willing and able to provide written informed consent.

Exclusion Criteria:

1. 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).

2. Have received monoclonal antibody therapy of any kind in the past.

3. Received vaccinations in the past 15 days prior to study entry.

4. Received antihistamines in the 6 weeks prior to study entry.

5. Received non-steroidal anti-inflammatory drugs (NSAIDs) in the 5-6 days prior to skin
test.

6. Any history of anaphylaxis, asthma, hypersensitivity reaction to a vaccine or drug
infusion, angioedema, or urticaria.

7. 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.

8. Have received any investigational agent within 60 days prior to screening.

9. 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.

10. 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.

11. Have an unexplained positive urine drug screen test for an illicit drug.

12. Have a confirmed positive hepatitis B surface antigen (HBsAg) or antibody to
hepatitis C virus (HCV).

13. 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.

14. 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.

15. Have a recent history of major surgery, internal organ biopsy, or major trauma.

16. Females who are pregnant or breast-feeding, or who plan to become pregnant during the
study.

17. Have a mental condition rendering the subject unable to understand the nature, scope,
and possible consequences of the study.

18. Show a positive reaction to the prick test for KD-247, i.e., =3 mm in diameter
greater than the negative control.



Age minimum: 18 Years
Age maximum: 64 Years
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infections

Intervention(s)

Drug: KD-247

Drug: Physiological saline

Secondary ID(s)

KD-1002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors