COVID-19 Updates

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Current Studies

​The AVRC HQ is actively recruiting for the following studies (last updated 7/9/20):


COVID-19

1. ACTG A5401 (Adapt Out COVID): This is a master protocol to evaluate the safety and efficacy of investigational agents for the treatment of symptomatic non-hospitalized adults with COVID-19.

What does the study involve?

A randomized, blinded, controlled, and adaptive protocol that allows investigational agents to be added and dropped throughout the course of the study. Agents will begin in a phase II evaluation and transition into a larger phase III evaluation if safety and efficacy is shown to be promising. The study consists of 28 days of intensive follow-up, then limited follow-up through 24 weeks.

Eligibility requirements:

  • ≥ 18 years of age
  • Positive SARS-CoV-2 infection (antigen or nucleic acid test from NP, oropharyngeal, nasal, or saliva) collected ≤ 7 days prior to study entry
  • Must begin treatment within 10 days from onset of symptoms:
    • Fever
    • Cough
    • Shortness of breath/difficulty breathing
    • Sore throat
    • Body pain/muscle aches
    • Fatigue
    • Headache
    • Chills
    • Nasal congestion
    • Nasal discharge
    • Loss of smell or taste
    • Nausea/vomiting
    • Diarrhea
    • Documented temp > 37.8⁰C
  • One or more of the above symptoms present within 48 hours of study entry
  • Agrees not to participate in another clinical trial for treatment of COVID-19 during study period
  • Additional criteria as appropriate for study treatment

Hepatitis C

1. ACTG A5380: People who are recently infected with Hepatitis C (HCV) are often considered to have acute HCV. People with acute HCV have a good chance of being cured of the infection when they are treated with a combination of two drugs within the first 6 months of being infected. This study is being done to see if a shorter course of treatment will be effective if started early in the infection (Step 1). In case of failure with this shorter course of treatment, a longer and different treatment regimen for HCV will be offered (Step 2).

What does the study involve?

Glecaprevir/pibrentasvir (G/P) Fixed-dose Combination (FDC) three pills by mouth once a day for 4 weeks (Step 1). If this medicine does not work for you after the 4 weeks or you become infected again while on study, you will be asked to take the G/P with or without Ribavirin for a longer time, 8-16 weeks longer. The study can last up to 28 weeks on Step 1 and up to an additonal 40 weeks if on Step 2.

Eligibility requirements:

  • Age 18+ years of age.
  • With or without HIV. If living with HIV, on a stable antiretroviral regimen or untreated due to lack of indication per physician.
  • HIV RNA < 50 and CD4 > 100.
  • May not have Hepatitis B.
  • Recently infected with HCV (in the past 6 months).
  • Cannot be pregnant or breastfeeding.
  • Must be willing to use birth control to prevent pregnancy.
  • Must be willing to come to study visits.
  • Must be able to swallow pills.
  • May not have other known liver disease.

HIV

1. ACTG A5359 - LATITUDE: This study is investigating if Long-Acting (LA) Injectable ART will be more successful for people who are non-adherent to their HIV medications than oral standard of care regimens. The main advantages of LA ART in this population include infrequent dosing and directly observed therapy. A challenge for participants is that, to be eligible to receive LA ART, they will need to attain virologic suppression through adherence to their SOC oral medications.

What does the study involve?

  • Step 1: During the first 24 weeks of the study, all study participants are prescribed an individualized oral study provided ART regimen. In addition to financial compensation for attending study visits, participants will receive a financial incentive (bonus) if they attend their week 2 visit and achieve specific drops in their viral loads at weeks 4, 8, 12, 16, and 20. Participants whose viral load is <50 copies at week 20 will be eligible for randomization at their week 24 visit.
  • Step 2: Randomization to LA ART vs. Oral SOC for 52 weeks
  • Step 3: LA ART continuation or crossover from oral SOC to LA ART for 52 weeks
  • Step 4: Observation on SOC for participants who received at least one dose of LA ART

Eligibility requirements:

  • HIV+ and ages 18 and older.
  • Prescribed ART for at least 6 months.
  • Screening HIV RNA >200 copies.
  • Evidence of non-adherence to HIV medications, as defined by: poor virologic response within the last 18 months in individuals who have been prescribed ART for at least 6 consecutive months OR lost to clinical follow-up within the last 18 months with ART non-adherence for >6 consecutive months.

2. ACTG A5375: This study will determine if a higher dose of levonorgestrel Emergency Contraception (LNG EC) (commonly called “Plan B” or the “Morning After Pill”) is needed to achieve high enough drug levels in girls and women who are taking medications that are known to decrease the effectiveness of this form of birth control.

What does the study involve?

At entry, participants will take their assigned standard or double dose EC and have their blood drawn 9 times over about 9 hours. Participants will return to the clinic for a blood draw at 24 and 48 hours after they took the EC dose. Participants will be contacted by study staff to complete a phone survey at weeks 1, 2, and 4.

Eligibility requirements:

  • Females ages 16 and older who have started menstruating.
  • Not currently pregnant, within 6 weeks of delivery, or currently breastfeeding an infant under 6 months of age.
  • Agree to use an approved non-hormonal birth control method during the study.
  • Currently taking either efavirenz, dolutegravir, or rifampin at entry.
  • Have either an HIV infection or an active TB infection.

3. ACTG A5377: An antibody is a type of protein that helps the body fight infections. Antibodies that develop naturally again HIV attach to one part of the virus so that the body's immune system can try to attack it. Antibodies are usually made by a person's own immune system, but they can also be manufactured like a drug. SAR441236 is an antibody that has been manufactured to attach to three parts of the HIV virus at the same time and to neutralize (or block) the ability of the virus to infect more cells.
A5377 is the first study in humans of SAR441236. The study will enroll two groups of people, but only enrolling Arm B at this time:
  • Arm A: People who are currently on an anti-HIV regimen with an undetectable HIV viral load will receive either SAR441236 or placebo in one of four increasing dosing groups.
  • Arm B: People with HIV who have never received anti-HIV medications will receive SAR441236 in one of four increasing dosing groups.

Purpose of this study:

  • If one infusion of SAR441236 is safe and tolerable
  • If one infusion of SAR441236 can reduce the amount of HIV in a person's blood
  • If multiple infusions (up to four) of SAR441236 are safe and tolerable and if they can reduce the amount of HIV in a person's blood more than just receiving just one infusion
  • Information about the amount of SAR441236 in the blood over time

Eligibility requirements:

  • People with HIV, 18 to 70 years of age with no active Hepatitis B or C infection.
Arm B
  • Have never taken anti-HIV medications, including PrEP
  • HIV viral load 5000 to 100,000 copies/mL
  • CD4 count greater or equal to 350 cells/mm3
  • Willing and able to start anti-HIV medications by day 28 of the study.

4. BRIDGES: This study aims to aims to help women access care for HIV and overcome barriers to treatment.

What does the study involve?

  • You will attend 3-10 visits, and your involvement will last for 6 months.
  • At 3 visits, complete a survey.
  • If selected to complete 10 visits, at the other 7 visits you will receive additional guidance on accessing HIV care and other support services.
  • Receive up to $185 for your time.

Eligibility requirements:

  • 18 years and older.
  • Self-identifying women, cisgender or transgender.
  • Living with HIV/AIDS

5. DIGITAL ADHERENCE: A novel wireless ingestible sensor system for measurement of medication adherence in HIV-positive men and women that are starting HIV treatment for the first time.

What does the study involve?

  • Nine study visits over a 16 week period with follow up out to 2 years.
  • Participants will receive HIV medication for 16 weeks at no cost.
  • At each study visit, you will be asked to respond to questions about your health and life style, how you are taking HIV medication and how you find using the technology.
  • Compensation provided for your time: $50/study visit.

Eligibility requirements:

  • Age 18 or older.
  • HIV-positive.

6. LAST GIFT: People at the end of their lives often have a unique perspective on life, death and altruism, and may hold the keys to curing HIV. This study takes the next steps in finding a cure for HIV by understanding how reservoirs are distributed throughout the body.

What does the study involve?

  • Regular visits, interviews, and blood draws during your lifetime.
  • Autopsy at the time of death.
  • Compensation provided for your time.

Eligibility requirements:

  • Persons with known HIV-infection, age 18 or older.
  • Agree to enroll in additional organ & tissue donation study.
  • On treatment for HIV at the time of enrollment.
  • Terminally-ill with less than 6 months to live.

7. THERAPY FOR CHRONIC PAIN: We want to understand chronic pain in persons aging with HIV and develop treatments to help manage pain.

What does the study involve?

  • Participation in group treatment for 8 weeks.

Eligibility requirements:

  • HIV+ men/women age 50 and older.
  • Pain not associated with cancer for at least 3 months.
  • English-speaking.

Sexual Health (for HIV-negative individuals)

1. URBAN NETWORK INTERACTIONS (UNI)

What does the study involve?

This is a social network study involving answering survey questions, getting an HIV test, and recruiting your friends to participate. This study takes place at the AVRC HQ, lasts 1 hour, and has financial compensation.

Eligibility requirements:

  • Men who have sex with men (MSM) and transgender individuals.
  • Age 18 years and older.
  • Live in San Diego.
  • Have a social network of 10+ people who you know well and talk to often.
  • Sexually active.

2. THRIVE: This study aims to understand HIV risk for women who have experienced sexual violence or who are sexually active.

What does the study involve?

  • Three study visits over three months, lasting no more than two hours each.
  • Each study visit includes a survey, blood draw, and vaginal exam.
  • Free testing for HIV, STIs, and pregnancy.
  • At home saliva sample collection after each study visit.
  • Referrals to care and other services (if needed).
  • Monetary compensation and transportation provided.

Eligibility requirements:

  • Women age 14 to 45.
  • Live in San Diego.
  • Sexually active within the past week OR have experienced sexual assault in the past week.

To enroll in or get more information about one of these clinical trials, please call the Screening Coordinator at (619) 543-3740 or email Marvin Hanashiro at mhanashiro@health.ucsd.edu.


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