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

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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:

  •  Healthy adults between the ages of 18 – 65 years

  • NO HIV, active hepatitis B, or active hepatitis C

  • Low risk for HIV infection

  • Non-smokers or former smokers (quit >1 year ago)

  • 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 participation

  • BMI between 18.5 – 29.9 kg/m2

  • 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

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