

CLINICAL TRIAL OF A NEXT-GENERATION, LONG ACTING INJECTABLE COMBINATION ANTIRETROVIRAL PLATFORM

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, all genders
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NO HIV, no active hepatitis B, no active hepatitis C
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Non-smokers or former smokers (quit >1 year ago)
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Low risk for HIV infection
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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
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Body Mass Index (BMI) less than 30
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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:
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Condom (male or female)
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Diaphragm or cervical cap
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Copper-based intrauterine device
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Vasectomy in the male partner
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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 and 57
(Entry visits may last from 9 hours to 3 days. Most other on-study visits will take 30-60 min.)
Medications administered during study:
1 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:
$440-$1240 (plus $150 if have a lymph node biopsy)
Contact:
Call or text us 206-773-7129