Purpose of this Study
People in this study will keep taking their regular HIV medicines. They will receive either a study medicine called GS 0415 or a placebo, which has no active medicine. The study medicine may be given as a shot under the skin or through a vein.
During the study, participants will have clinic visits for physical exams, blood and urine tests, heart tests, and HIV testing. Depending on the study group, they may receive one dose or up to five doses of the study medicine. Some visits will include staying overnight in the clinic so doctors can watch for side effects and make sure the treatment is safe.
The study lasts about three months and is designed to learn more about the safety and effects of GS 0415 in people living with HIV.
Who Can Participate?
Eligibility
People can join this study if they are between 18 and 65 years old and have HIV 1. They must have been taking the same HIV medicines for at least 12 months, and their treatment cannot include a type of medicine called an entry inhibitor. Their HIV must be well controlled, with very low levels of the virus in their blood. They must also have a healthy immune system with a CD4 count of at least 350 and be in generally good health. Participants must be able to attend all study visits and follow the study procedures.
Age Range
18-65
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study is testing a new medicine called GS 0415 in people who have HIV. Researchers want to learn if the medicine is safe and how the body reacts to it. They are especially interested in whether GS 0415 can help target HIV that stays hidden inside the body, even when people are taking regular HIV medicines. What doctors learn from this study may help develop better HIV treatments in the future.
Locations
Duke University Hospital
Pickett Road Research
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
DIA05: A First-in-Human Phase 1b, Single-Blind, Placebo-controlled Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Evaluate Safety and Pharmacokinetics of GS-0415 in People With HIV-1 who are Virologically Suppressed on Antiretroviral Treatment
Principal Investigator
Mehri
McKellar
Protocol Number
PRO00120333
Phase
I
Enrollment Status
Pending Open to Enrollment