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(MMA-0613) A study of the safety, tolerability and pharmacokinetics of experimental drug KD-247


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A study of the safety, tolerability, and pharmacokinetics of KD-247, a humanized monoclonal antibody that recognizes the prinicipal neutralizing determinant of HIV-1 in asymptomatic HIV-1 seropositive individuals who are not receiving concurrent therapy

Principal Investigator:
Martin H. Markowitz M.D.

Investigators:
Martin H. Markowitz M.D.

Contact Information:
Melissa La Mar
The Rockefeller Univesity
1230 York Avenue
New York , NY 10065
Telephone: (212) 327-7280
Email: mlamar@adarc.org
Enrollment Status:
Closed to Enrollment

Brief Summary of Protocol:
The reason for doing this research is to determine the safety and tolerability of 3 infusions (the introduction of fluid into a vein) over 2 weeks of the experimental study drug KD-247 in HIV-1 seropositive (infected) individuals.

We also want to know how much of the drug gets into your bloodstream and what effect KD-247 has on plasma HIV-1 RNA load (amount of virus in your blood, also called ‘viral load’) and on CD4+ T cell counts (CD4+ count measures the number of a type of white blood cell in the body that fights infection).



Detailed Description of Protocol:
Your participation in the study will last approximately 17 weeks, which includes a minimum 3 weeks between screening and baseline, 2 weeks of weekly KD-247 or placebo intravenous (IV) infusions given on three occasions 1 week apart, and a 12-week follow-up period.

At the time you get infusions of KD-247 there will be pharmacokinetic studies done. Pharmacokinetic (PK) means determining how much study drug is getting into your blood. PK blood samples will be collected (drawn from an IV that is placed in a vein in your arm) at the following times

Day 1 and 15: pre-dose, 30 minutes, and 1 hr, 2 hrs, 3 hrs, 6hrs, and 24 hours from start of dose infusion.

On Day 8 (infusion #2) blood samples for PK will be collected at pre-dose, 2 hrs and 24 hrs from start of dose infusion.

On Days 17 and 18 (48 hrs and 72 hours after Day 15 treatment [infusion #3]), a single blood sample will be collected. You will also have one PK sample collected at each visit for Week 3, Week 4, Week 7, Week 10 and Week 14 (1, 2, 5, 8 and 12 weeks after the last infusion, respectively).

The study consists of 15 visits. Profile:
If you join the research study, you will take part for about 17 weeks. The research study as a whole will last about 1 year.

About 36 people will take part in the research study. About 6 participants will be recruited at this site.



What specifically makes a person eligible for the study?
You may be eligible to enter this study:

• You have HIV-1 infection

• You are between18-64 years of age (male or female)

• You have not been treated with, or have been off antiretroviral drugs for at least 8 weeks prior to screening.

• You weigh 45-100 kg (99-220 lbs).

• You are willing and able to provide written informed consent.

• If female:

• You are a woman of non-childbearing potential, defined as either surgically sterile or at least 1-year post-menopausal, or

• You are a woman of childbearing potential using a highly effective method of contraception.

Gender:
Both

Age(s):
18-64 years old

Children permitted to participate:
No

Potential Benefits.....
You will not receive any direct medical benefit from taking part in this study. The potential benefit to society may be information gained on the safety and effectiveness of the study drug for patients in the future.



Compensation:
There is no cost to you for being in this research study.

Volunteers will receive $2,100 for participation.