6
项与 VRC-HIVMAB060-00-AB 相关的临床试验An Exploratory Study of Combination Therapy With VRC-HIVMAB060-00-AB (VRC01) and 10-1074 in HIVInfected Individuals Undergoing Sequential Treatment Interruptions
Background:
A daily drug combination can keep human immunodeficiency virus (HIV) levels low for a long time. But if this combination antiretroviral therapy (ART) stops, HIV levels go back up. People can also develop resistance or permanent side effects. Researchers want to see if 2 new drugs can help control HIV when a person is not on ART.
Objective:
To see if VRC01 and 10-1074 are safe and control HIV when a person is not on ART.
Eligibility:
Adults 18-65 with HIV
Design:
All participants must agree to practice safer sex. Those who can get pregnant will have a pregnancy test every visit.
Participants will be screened with:
Physical exam
Medicine review
Blood and urine tests
Some participants may need to change their HIV medicine for a brief period of time during the study.
A few weeks later, participants will repeat screening tests and stop taking their HIV medicines.
Interruption phase 1: Participants will have blood tests every 2 weeks, and repeat screening tests every 4 weeks.
Treatment phase: Once their HIV reaches a certain level in the blood, participants will get the 2 study drugs or a salt water placebo. They will not know which they get. Each substance will be given through a thin tube in an arm vein for about 1 hour. Participants will restart their HIV medicines and repeat screening tests every 4 weeks.
Interruption phase 2: Once the level of HIV in the blood becomes undetectable for 3 months, participants will again stop taking their HIV medicines and have blood tests every 2 weeks to monitor the level of HIV in the blood.
Participants will restart their medicines by week 24. They will start sooner if they have certain symptoms or blood levels of HIV become too high. They will repeat most screening tests 3 times over 24 weeks.
PET Imaging of Radiolabeled Anti-HIV-1 Envelope Monoclonal Antibody (VRC01)
This is a single center exploratory imaging study involving one intravenous microdose of 89Zr-DFO-VRC01 followed by whole-body PET-MR imaging in HIV infected individuals and healthy volunteers. Imaging data will be obtained from up to four static PE-MR images in order to determine dosimetry and temporal tissue uptake/tissue distribution of 89Zr-DFO-VRC01. This is not a treatment study of the biological activity of 89Zr-DFO-VRC01 to impact HIV persistence.
VRC 606: A Phase 1, Dose-Escalation Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB080-00-AB (VRC01LS) and VRC-HIVMAB060-00-AB (VRC01), Administered Intravenously or Subcutaneously to Healthy Adults
Background:
Antibodies help the body fight infection. VRC01LS is an antibody directed against HIV virus. HIV attacks the immune system. In animals, VRC01LS inactivated many types of HIV viruses. Researchers want to see if it does this in people.
Objectives:
To see if VRC01LS is safe and well-tolerated in people. To see what level of VRC01LS is maintained in people and if they develop an immune response to it.
Eligibility:
Healthy people ages 18 to 50
Design:
Participants will be screened in protocol number VRC 500 (NIH 11-I-0164) with medical history, physical exam, and blood and urine tests.
The study will last 24 to 48 weeks. Visits will last 2 to 8 hours.
Participants will get VRC01LS through either:
A needle in an arm vein or
A small needle placed into the fatty tissue under the skin of the abdomen, thigh, or arm.
Participants will be assigned to 1 of 6 groups.
Groups 1 to 4 will get 1 dose of VRC01LS. They will have follow-up visits through week 24.
Groups 5 and 6 will get 1 dose of VRC01LS every 12 weeks (3 doses). They will have 4 to 5 visits between the second and third dose, and follow-up visits through week 48.
Participants will have 1 to 3 follow-up visits in the week after receiving VRC01LS. They will record their temperature and keep a diary of symptoms for 3 days after a dose. They may have additional unscheduled visits.
At each visit, participants will have a physical exam and may have blood and urine tests.
100 项与 VRC-HIVMAB060-00-AB 相关的临床结果
100 项与 VRC-HIVMAB060-00-AB 相关的转化医学
100 项与 VRC-HIVMAB060-00-AB 相关的专利（医药）
100 项与 VRC-HIVMAB060-00-AB 相关的药物交易
