Current Studies

CMV-specific HIV-CAR T cells as Immunotherapy for HIV (Research for an HIV Cure) 

This is a first in-human, open-label pilot study that does not have a placebo and focuses on evaluating the safety and feasibility of CMV/HIV-CAR T cells in people with HIV as a promising method to effectively eliminate the virus. Eligible participants temporarily interrupt their ART regimen for 4 days to facilitate the production of the CAR T cells. After this, each participant receives an intravenous infusion of autologous CMV/HIV-CAR T cells at study entry and is followed very closely over the next two years, which includes a thorough evaluation of potential toxicities, their nature, frequency, severity, timing, and duration. More about CMV-specific HIV-CAR T cells.

Eligibility requirements include:

• Be a person with HIV and 18 years of age or older with undetectable HIV viral loads for the past 48 weeks.
• Must have a caregiver that can live with the participant for two weeks in Duarte, CA (Los Angeles County).
• Not be pregnant or breastfeeding or planning to get pregnant.
• Be willing to temporarily interrupt your ART regimen for four days before leukapheresis.
• Maintain a CD4+ cell count of 450 or higher.
• No previous AIDS diagnosis.

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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.

Eligibility requirements include:

• You must be in one of the following two groups:
• • People who took anti-HIV drugs in the past to control their HIV but who have not been taking any anti-HIV drugs for at least 6 months and whose HIV is still very low or not detectable (meaning that it cannot be measured by standard tests).
  • People who are taking anti-HIV drugs but whose HIV level is still detectable (meaning that it can be measured by standard tests).
• You must also:
• • Be a person with HIV, ≥ 18 years of age.
  • 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.

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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.

Eligibility requirements include:

• Living with HIV and age 18 to 70 years old.
• Be willing to take a superagonist and broadly neutralizing antibodies and complete study-related tests.
• Be willing to temporarily stop taking antiretrovirals or ART.

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ACTG 5403 (GET IT RIgHT)

The purpose of this study is to determine the best combo of antiretroviral therapy for transgender women (TW) living with HIV who take feminization hormonal therapy (FHT). All participants will receive FHT. The study will determine if TW remain undetectable while receiving FHT for 48 weeks. Additionally, it will assess if hormone levels change based on the type of HIV medications taken.

Eligibility requirements include:

• At least 18 years old and living with HIV taking certain HIV medications with a viral load of less than 400 copies.
• Identify as a TW or as a female or transfeminine person with male sex assigned at birth.
• Desire to initiate or restart FHT.

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ARTISTRY-1

The purpose of this study is to compare taking oral bictegravir/lenacapavir versus a complex ART regimen in people with HIV.

Eligibility requirements include:

• People with HIV and 18 years of age or older on a complex ART regimen and undetectable for at least 6 months.
• A complex ART regimen includes
  • Containing a boosed PI or NNRTI + 1 other agent.
  • Taking 2 or more pill/dayor requiring dosing more than once daily.

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ARTISTRY-2

The purpose of this study is to compare taking oral bictegravir/lenacapavir versus Biktarvy in people with HIV.

Eligibility requirements include:

• People with HIV at least 18 years of age taking Biktarvy and undetectable for at least 6 months.
• No documented resistance to Biktarvy or lenacapavir.
• No prior use of lenacapavir.

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DEPTH (Doxycycline for Emphysema in People Living with HIV)

This is a research study to evaluate if the medication doxycycline, a commonly used antibiotic, can slow the damage to the lungs caused by emphysema in people who also have HIV. Emphysema is more prevalent in people living with HIV and may progress faster than in HIV-negative individuals. Doxycycline is approved by the FDA to treat or prevent a variety of infections and conditions. It has not been approved to treat emphysema in people living with HIV, so the use in this study is considered investigational.

The study involves about 10 study visits over 18–20 months, including pulmonary testing at some visits, and 2 chest CT scans.

Eligibility requirements include:

• Living with HIV and stable on treatment
• At least 30 years old, and a current or former smoker
• Willing to take study drug (doxycycline or placebo) twice daily for 18 months
• You do not need to be formally diagnosed with emphysema to participate.

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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. More about the Last Gift Study.

Eligibility requirements include:

• Living with HIV and age 18 years or older
• Agree to body tissue donation after death
• Have been diagnosed with a life-shortening illness (e.g. cancer, ALS)

No active studies at this time.

TRUVIAN

This research study seeks to test the performance of an investigational blood analyzer to make routine health tests convenient and get results fast. Eligible participants will receive $75 as compensation for a clinic visit and blood draw.

Eligibility requirements include:

• You are at least 18 years old.
• Healthy volunteers with no chronic medical conditions.

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.

Eligibility requirements include:

• 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.

PURPOSE-3 (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 include:

• You are at least 18 years old and a cisgender woman.
• You are sexually active.

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PURPOSE-4 (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 among people who inject drugs.

Eligibility requirements include:

• You are at least 18 years old.
• Have had injection paraphernalia sharing within the past 30 days.
• Evidence of a recent injection.