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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 9/22/22):


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 5355

The purpose of this study is to see if an investigational vaccine for CMV (called Triplex®) is safe when given to people with both HIV and CMV. This study will also collect information on the effectiveness of Triplex® to reduce inflammation and immune activation markers compared to a placebo. This will be the first time that this type of information will be collected. 


What does the study involve? 
When you enter this study, you will be randomized to one of two study groups. You will have double the chance of receiving Triplex® versus the placebo. You must continue to take your anti-HIV drugs throughout the study. You will also 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 use of other drugs.
      • For 4 weeks following each study injection, you will complete a daily study diary (which is also known as a study vaccination report card); you will need to take and record your body temperature for the first 5 days each time.
      • At several of the clinic visits, saliva, rectal swabs, and/or genital fluid (semen or vaginal swab) will be collected.
Eligibility requirements:
    • Living with HIV-1 and with cytomegalovirus (CMV).
    • Be between 18 and 65 years old.
    • On anti-HIV medications that are controlling your HIV for at least the past year.


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 5383

The purpose of this study is to learn whether people living with well-controlled HIV and symptom-free cytomegalovirus (CMV) can reduce inflammation by taking a drug approved by the FDA (called letermovir) to prevent CMV disease.


What does the study involve? 
There will be treatment provided in this study. Letermovir is a pill given by mouth once a day that is FDA-approved to prevent CMV disease. There are two study treatment groups. You will have a 50/50 chance of going into one of the two groups. Participants in one group will get letermovir and participants in the other group will not get any additional medications.

Eligibility requirements:
    • Living with HIV and ≥40 years of age.
    • On continuous anti-HIV medications for at least 48 months with no interruptions >7 days.
    • At least 48 months of undetectable viral loads, although a one-time, low-level viral load is OK.
    • Have not made a significant change in HIV medication in the past 12 weeks, or plan to make changes during study participation.
    • No heart arrhythmias/ irregular heartbeats.
    • No active Hepatitis B or hepatitis C within 24 weeks.
    • Not currently using any of the following HIV medications: efavirenz, nevirapine, etravirine, lopinavir/ritonavir, or once a day dosing of raltegravir (twice a day dosing is OK).
    • While people with any CD4 count are eligible, the study is particularly interested in recruiting people with low CD4 counts (i.e., <350 cells/mm3).
    • While people of all gender identities are eligible, the study is particularly interested in recruiting cis-gender women and transgender women receiving gender-affirming hormones.


ACTG 5386 (N-803 with or without bNAbs for HIV-1 control in participants living with HIV-1 on suppressive ART)

Scientists are looking for ways to effectively clear HIV that rests in areas of the body where standard antiretroviral treatment (ART) is unable to reach. IL-15 superagonist (N-803) appears to reactivate HIV that is "asleep" and is also thought to increase the body's natural immune response to HIV. Broadly neutralizing antibodies (bNAbs), such as 10-1074 and VRC07-523LS, have been shown to control growth of HIV in the blood and to increase the body's immune response to HIV. N-803 alone or in combination with bNAbs may provide greater control of HIV than previous efforts. 


What does the study involve? 
    • Eight doses of N-803 given by needle under the skin; half of participants will receive two doses of 10-1074 and one dose of VRC07-523LS given intravenously (through a catheter in the vein).
    • Blood and urine tests at scheduled clinic visits for safety evaluations and to check your immune function.
    • Leukapheresis (collection of immune cells through a catheter in the vein) (a procedure similar to donating platelets) will be completed twice.
    • Lymph node fine-needle aspirate (a type of biopsy using a needle) is an optional procedure which will be done prior to study entry and at Week 13.
Eligibility requirements:
    • Living with HIV.
    • Have a low or undetectable viral load for at least 2 years.
    • Be willing to take a superagonist and broadly neutralizing antibodies and complete study-related tests.
    • Agree to use contraception/birth control methods.
    • Be between 18 and 70 years old.
    • Be willing to temporarily stop taking antiretrovirals or ART.


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.

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.

Sexual Health (for HIV-negative individuals)

PURPOSE-2 (INJECTABLE PREP STUDY)

We are conducting a clinical study to see whether an investigational twice-a-year injection medication can help reduce the risk of getting HIV from sex.

Eligibility requirements:

  • You are at least 18 years old.
  • You haven't been tested for HIV in the past 3 months.
  • You are sexually active and having receptive anal sex.

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.