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First in Human

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

Study ID: 00007490
Start Date: 04/04/2023
End Date: 04/30/2024

Investigator(s)
Rachel Bender-Ignacio, MD

Accepts Healthy Volunteers?
Yes

Study Site(s)

UW Positive Research

325 9th Ave
Seattle, Washington 98104



Interested?

Use the link below to send a message to the study coordinator, or call the number above to speak directly with a study representative.

I am interested in this research study.

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