CLINICAL TRIAL OF A NEXT-GENERATION, LONG ACTING INJECTABLE COMBINATION ANTIRETROVIRAL PLATFORM
CLOSED TO ENROLLMENT
Main Purpose:
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 used to treat HIV.
Main Requirements:
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Healthy adults between the ages of 18 – 65 years
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NO HIV, active hepatitis B, or active hepatitis C
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Low risk for HIV infection
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Non-smokers or former smokers (quit >1 year ago)
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Not taking ANY prescription or over the counter medications (that cannot be safely stopped)
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No active drug or alcohol abuse
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If use cannabis, willing to stop cannabis use for 2 weeks before and during study participation
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BMI between 18.5 – 29.9 kg/m2
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Persons of child-bearing potential must use 2 of the following types of contraceptives throughout the study:
o Condom (male or female)
o Diaphragm or cervical cap
o Copper-based intrauterine device
o Vasectomy in the male partners -
No tattoos on abdomen near the belly-button
Length of Study (per person):
Approximately 2 Months
Schedule of Study Appointments:
Screening, Entry, Days 1, 2, 3, 7, 10, 14, 21, 28, 35, 49, 57, and 64
(Entry visits may last from 9 hours to 25 hours. Most other on-study visits will take 30-60 min.)
Medications administered during study:
One dose given as 2 subcutaneous injection of a combination of low doses of lopinavir, ritonavir, and tenofovir
Study Procedures:
Medical histories, Physical exams, Blood draws.
Some participants will have a lymph node biopsy
Reimbursement:
up to $1360 (plus $150 if have a lymph node biopsy)
Contact:
Call or text us 206-773-7129 or email at positiveresearch@uw.edu