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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, all genders

  • NO HIV, 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 Mass Index (BMI) less than 30

  • 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

    • Copper-based intrauterine device

    • Vasectomy in the male partner

  • 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

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