COVID-19 Updates

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Current Studies

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

The AVRC HQ is actively recruiting for the following studies on COVID-19, Hepatitis C, HIV, and sexual health (last updated 9/30/21):


COVID-19

ACTG 5401 (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

ACTG 5380 (PURGE-C)

People who recently contracted 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

ACTG 5321 (AHRC)

Studying differences and changes over time in HIV reservoirs (groups of HIV-infected cells that 'hide' from anti-HIV medications) and attempting to answer questions about the ways that HIV infection is controlled. This may have to do with a person’s viral load and CD4 count, when they started their anti-HIV medications, and genetic factors.

What does the study involve?

Participants will attend visits twice a year for about seven years. At these visits, blood and a small amount of hair will be collected from all participants. Some participants who meet additional criteria may be asked to have two additional procedures: rectal biopsy (a procedure that allows the collection of small pieces of rectal tissue) and leukapheresis (a procedure to collect white blood cells). These procedures are optional and will only start after a participant has been in the study at least six months.

Eligibility requirements
You must be in one of the following three groups:
    • Group 1: Participated in ACTG study A5276s or A5001 (if you were a part of A5001 you must have also participated in either ACTG 384, A5095, A5142, A5202, or A5257).
    • Group 2: Began your anti-HIV medications during the very early part of your HIV infection.
    • Group 3: Had a viral load less than 500 copies/mL prior to starting any anti-HIV medications.
You must also:
    • Be a person living with HIV, ≥ 18 years of age.
    • Be taking anti-HIV medications that have been controlling your viral load for 1-2 years (depending on which Group you will be in).
    • Have never stopped your anti-HIV medications for more than 3 weeks.
    • Have no active hepatitis B or C infection, an autoimmune, disorder or a condition requiring steroid therapy.


ACTG 5357

This study will see if cabotegravir and VRC01LS (a monoclonal antibody) work well when taken together to keep HIV levels low, and will also evaluate the safety of the drug combination.


What does the study involve? 
Participants will be registered to three “steps”:
    • Step 1: All participants will discontinue their current anti-HIV medications except for “nukes” and start oral CAB.
    • Step 2: Participants may receive CAB long-acting drug by injection every 4 weeks, plus VRC01LS infusion by IV every 12 weeks.
    • Step 3: Participants will be switched back to a standard-of-care oral HIV regimen.
Eligibility requirements:
    • Between the ages 18 and older.
    • On stable anti-HIV medications for a minimum of 8 weeks.
    • With a CD4+ cell count greater than or equal to 350.
    • Having an undetectable HIV viral load (less than 40 copies).
    • With no current Hepatitis B or C infection.
    • With no history of seizures or treatment for seizures within the past 2 years.
    • With a susceptibility to VRC01LS based on assay done at screening.


ACTG 5359 (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:

  • Living with 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.

ACTG 5379 (BEe-HIVe)

Vaccination for hepatitis B in individuals living with HIV does not always work, especially in those with impaired immune systems or ability to fight infection. Prevention of hepatitis B in individuals living with HIV has primarily been done by vaccinating with a series of 3 shots given over 6 months. A new vaccine, called HEPLISAV-B, has been approved that may provide a better response than what has currently been used. The researchers will study whether this vaccine will prove to be more effective than the current standard.


What does the study involve?
    • HEPLISAV-B vaccine given at entry and at 4 weeks or
    • HEPLISAV-B vaccine given at entry, 4 weeks and 24 weeks or
    • Engerix-B vaccine given at entry, 4 weeks and 24 weeks.
Eligibility requirements:
    • Living with HIV.
    • Been on HIV treatment for more than 56 days.
    • Previously received vaccines for hepatitis B, but the vaccines didn’t work.
    • There will be a small group of participants (73) who have never been vaccinated for hepatitis B.
    • CD4 cell count (the number of white blood cells that fight infection) more than 100.
    • HIV viral load (how much HIV is in the body) less than 1000.
    • In the group vaccinated with a hepatitis B vaccine, the vaccination was over 168 days ago.
    • No previous hepatitis B infection or exposure to hepatitis B infection.


ACTG 5391 (Do IT)

This research study is trying to find out if people living with HIV who had > 10% weight gain after starting an antiretroviral therapy (ART) regimen that included an INSTI in combination with TAF/FTC (or TAF/3TC) could gain less weight, or maybe lose weight, after switching to an ART regimen containing doravirine (DOR) with either TAF/FTC (or TAF/3TC), or the related medication tenofovir disoproxil fumarate/emtricitabine (TDF/FTC [or TDF/3TC]). DOR is an FDA-approved antiretroviral drug for the treatment of HIV-1 and a member of the non-nucleoside reverse transcriptase inhibitor (NNRTI) medication class. In multiple studies, DOR was shown to be just as effective as INSTI medications for treating HIV.

What does the study involve? 
When you enter this study, you will be randomized (assigned by chance, as if by roll of dice) to one of three study groups. Because the randomization is equal, you will have a 33% chance of being in any of the following study groups:
  • Group 1: You will continue taking TAF/FTC (or TAF/3TC) but will stop your INSTI and take DOR; your ART will be DOR+TAF/FTC (or TAF/3TC) for 48 weeks.
  • Group 2: You will stop your INSTI and TAF/FTC (or TAF/3TC) and will switch to DOR+TDF/FTC (or TDF/3TC) for 48 weeks.
  • Group 3: You will continue your current ART of an INSTI+TAF/FTC (or TAF/3TC) for 48 weeks.
Everyone on study will have:
    • Blood and urine tests at scheduled clinic visits for safety evaluations and other research testing.
    • Questionnaires asking for information on adherence to ART and diet and exercise habits.
    • DEXA Scan (Dual-Energy X-Ray Absorptiometry) to measure lean muscle, body fat and bone density. 

Eligibility requirements:

  • Living with HIV-1.
  • Be 18 years old.
  • Currently on an Integrase Inhibitor (INSTI) containing regimen (BIC, DTG or RAL), with > 48 weeks INSTI+TAF/FTC (or TAF/3TC) dosing prior to study entry.
  • Have experienced > 10% weight gain in the 1-3 years after starting these medications.
  • Have a body mass index (BMI) >27.5 kg/m2.
  • Have study related tests done, including a DEXA Scan (X-Ray Scan measuring measure lean muscle, body fat and bone density).
  • Agree to use contraception/birth control methods if capable of becoming pregnant.
  • Be willing to change ART if randomized to Arms 1 or 2.

INSTACARE

People with HIV who are out of care are at greater risk of transmitting HIV compared to people on HIV treatment with suppressed levels of virus. To date, there are no interventions that have been shown to successfully link this "out of care" population back into care and successfully maintain viral suppression. This study will test a strategy of providing immediate HIV therapy, intensive linkage support services, and a randomized behavioral intervention.

What does the study involve?

  • 4 in-person study visits; first visit lasts about 3 hours, follow-up visits last 1 hour.
  • Starting on HIV medications right away.
  • Participation in a one-time, 60 minute health intervention.
  • Participants will be asked about their medical history, complete a series of questionnaires, and have blood drawn at each visit.
  • Compensation provided for time and transportation; meal support available.

Eligibility requirements:

  • Persons aged 18 years and older living with HIV
  • Out of HIV care and not currently on HIV medications.

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:

  • Living with HIV, 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.

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:

  • Living with HIV, age 50 and older.
  • Pain not associated with cancer for at least 3 months.
  • English-speaking.

Sexual Health (for HIV-negative individuals)

SUBVERT (BACTERIAL VAGINOSIS STUDY)

We are looking for healthy women with a current vaginal bacterial infection (also called Bacterial Vaginosis or BV) and a history of at least two previous episodes of BV to take part in a study of a vaginal product called TOL-463 vaginal insert. TOL-463 is a non-azole vaginal anti-infective drug that may be used for suppression of recurrent BV in women. 

What does the study involve?

  • Five study visits over approximately a 100 day period.
  • Each study visit consists of a pelvic exam, vaginal swab collection, and a brief history and physical.
  • All participants will initially receive oral metronidazole or another CDC recommended BV treatment, and then will be randomly selected to receive suppressive BV treatment (TOL-463 Insert) or placebo at no cost.
  • Testing for STDs.
  • Compensation up to $225 provided for your time and effort.

Eligibility requirements:

  • Age 18 to 55, sex assigned female at birth and identify as female.
  • Have current or recurrent BV.
  • Not pregnant or breastfeeding.

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.