21 Apr First in Human
First in human clinical trial of a next generation, long-acting injectable, combination anti-retroviral therapy platform. This study will look at drug levels in the blood over time and the safety of a single injection of a new investigational medicine that combines existing short-acting oral drugs to treat HIV. The length of the study is approximately 2 months. There is a single under the skin injection of a combination of low doses of lopinavir, ritonavir, and tenofovir. Reimbursement will range from $440-$1240, depending on your chosen level of participation. Additional $150 for lymph node biopsies. Call/text UW Positive Research at 206-773-7129.
Participant Eligibility
Healthy adults between the ages of 18-65
All genders
HIV Negative
No active hepatitis B
No active hepatitis C
Non-smokers or former smokers (quit >1 year ago)
Low risk for HIV infection
Not taking ANY prescription or over the counter medications (that cannot be safely stopped)
No active drug or alcohol abuse
If use cannabis, willing to stop cannabis use for 2 weeks before and during study
Body size (weight for height) normal or overweight (BMI 18.5-29.9)
Women of non-child-bearing potential
(Either no sex with men, or post-menopause or copper IUD or hysterectomy or tubal ligation or ovaries removed. Hormones of any type are exclusions.)
Persons of child-bearing potential must use 2 of the following types of contraceptives throughout the study: Condom (male or female), Diaphragm or cervical cap with spermicide, Copper-based intrauterine device, Vasectomy in the male partner
No tattoos on abdomen near the belly-button
Contact
Eli Burnham, PA-C
(206) 773-7129
Additional Study Details
Full Study Title
0 First in human clinical trial of a next generation, long-acting injectable, combination antiretroviral therapy platform Phase I Study
Investigator(s)
Rachel Bender-Ignacio, MD
Accepts Healthy Volunteers?
Yes
Study Site(s)
UW Positive Research
325 9th Ave
Seattle, Washington 98104
