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.

Eligibility requirements include:

• Age 18+ years of age.
• Have had a positive diagnosis of COVID-19 within the past 3 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 3 days (with one or more symptoms ongoing).
  

HIV

• ​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).​

• 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.

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:

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.​

Eligibility requirements:

• ​Living with HIV and age 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.

DEPTH (Doxycycline for Emphysema in People Living with HIV​)  *NEW*

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.
  

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.
  

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 include​:

• 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.