To enroll in or obtain more information about our clinical trials, please call the Screening Coordinator at (619) 543-3740 or email the AVRC at avrcmarketing@health.ucsd.edu.
The AVRC is actively recruiting for the following studies on COVID-19, HIV, and sexual health (last updated 18MAY2023):
COVID-19
SCORPIO-HR/ACTIV-2D
Several treatments are now being used for COVID-19. However, new treatment options are needed to help people recover faster from COVID-19. The SCORPIO-HR study is a clinical research study looking at whether an investigational drug for COVID-19 can help resolve COVID-19 symptoms faster in people who have tested positive.
What does the study involve?
If you take part, you will be in the SCORPIO-HR study for about 24 weeks and will have at least 8 study visits for assessments. Study visits may be completed at the AVRC, at your home (if feasible), or over the phone (telemedicine visits). Participants may be allowed to receive locally available standard of care treatment for COVID-19 during the study, except for Paxlovid (nirmatrelvir/ritonavir) or other medications that can interact with the investigational drug.
Eligibility requirements:
- Age 18+ years of age.
- Have had a positive diagnosis of COVID-19 within the past 5 days.
- Are experiencing COVID-19 symptoms such as coughing, shortness of breath, feeling feverish, fatigue, nausea, chills, headaches, or sore throat, among others, within the past 5 days (with one or more symptoms ongoing).
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 two groups:
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.
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.
- No evidence of any clinically relevant RPV or INSTI resistance-associated mutations.
- Agree to use contraception/birth control methods if capable of becoming pregnant.
- No history of unstable or poorly controlled seizure disorder.
- No history of liver cirrhosis or advanced liver disease.
- No history of or current active hepatitis B.
- No current or anticipated need for chronic anti-coagulation therapy.
- Wiling to receive injections,
- No previous use of Cabotegravir.
- 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.
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.
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 PWH who
are obese (BMI greater than or equal to 30 kg/m2) and are on a treatment regimen that includes an
INSTI in combination with TAF/FTC (or TAF/3TC) could gain less weight, or maybe
lose weight, after switching to a 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. 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.
- 18 years or older.Currently on an Integrase Inhibitor (INSTI) containing regimen (BIC, DTG or RAL), with more than 48 weeks INSTI+TAF/FTC (or TAF/3TC) dosing prior to study entry.
- Have a body mass index (BMI) greater than or equal to 30 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.
ACTG 5415 *NEW*
We are doing this study to learn more about the
effects of Cenicriviroc (CVC) on inflammation and heart health in people living with HIV. We
want to learn if CVC can lower vascular inflammation by looking at the aorta
(the main artery in your body) through a test named FDG PET- CT. This test will
be done before starting study drug and at study week 24.
What does the study involve?
- You will be randomly assigned to receive CVC 150 mg by mouth once a day or placebo by mouth once a day. You will have twice the chance of getting CVC versus placebo.
- For participants who are on an efavirenz (EFV)-based regimen, dosing will be 300 mg by mouth once a day in the morning with food.
Eligibility requirements:
- Living with HIV and be 45 years of age or older.
- Be on continuous HIV treatment for the last 48 weeks with undetectable HIV viral load in last 48 weeks.
- On NNRTI-based or unboosted INSTI-based ART regimen.
- Have no active heart or blood vessel disease or be at increased risk for heart disease.
- Not pregnant or breastfeeding.
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.
MPOX
A5418 (STOMP)
Tecovirimat (also known as TPOXX) is a drug that may help to treat infections caused by pox viruses. Tecovirimat is approved by the Food and Drug Administration (FDA) to treat smallpox in adults and children. Its use in this study is considered investigational. An investigational use is one that has not been approved by the FDA. Tecovirimat has been approved for use in this study based only on data from animals. We don’t know for sure if it works to treat any infections in people. The FDA has reviewed information on tecovirimat and determined that tecovirimat may help treat infection, including serious or potentially life-threatening disease from poxviruses.
We are doing this study to see if tecovirimat is safe and whether it helps treat MPOX in people.
What does the study involve?
The study-provided treatment is Tecovirimat or Placebo for Tecovirimat. Most people will be randomly assigned (like flipping a coin or rolling dice) to a study group. Twice as many people will receive active study drug than the placebo in this study. So, you are twice as likely to receive “real” study drug. Some people, because of their age or their medical history, will be assigned to receive tecovirimat instead of being randomly assigned to a study group.
Eligibility requirements:
- Laboratory-confirmed or presumptive MPOX infection.
- MPOX illness of less than 14 days duration.
- At least one active (not yet scabbed) skin lesion, mouth lesion, or proctitis (inflammation of the lining of the rectum) with or without visible ulcers.
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 the AVRC at avrcmarketing@health.ucsd.edu.