Infectious Disease

Official Title

Decay of HIV-1 Reservoirs in Participants on Long-Term Antiretroviral Therapy: The ACTG HIV Reservoirs Cohort (AHRC) Study

Purpose

The purpose of this study is to examine longitudinal changes in HIV-1 reservoirs among participants with HIV-1 who are either currently receiving antiretroviral therapy (ART) or who received ART previously. Participants will undergo blood and hair sample collections for immunologic, virologic, and pharmacologic evaluations to study HIV-1 reservoirs in the body.

Could this study be right for you?

This study is currently only enrolling in Group 6 which includes participants who acquired HIV while taking long-acting cabotegravir (CAB).

Age Range

18 years and up

Official Title

A Double-Blind, Randomized, Placebo-Controlled Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined with ART Initiation during Acute HIV Infection to Induce HIV Remission

Purpose

The purpose of this study is to evaluate the safety and efficacy of combination bNAbs in addition to ART initiated during acute HIV infection and to evaluate the impact on HIV viral reservoirs.

Could this study be right for you?

• Newly diagnosed HIV+ individuals who have not yet started antiretroviral therapy (ART)
• Willingness to start ART at enrollment
• Ability and willingness to participate in scheduled study visits and analytic treatment interruption (ATI)
• Weight <115kg

Age Range

18 - 70 years

Official Title

A Randomized, Placebo-Controlled, Double-Blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Human Mpox Disease

Purpose

This study will evaluate the safety and efficacy of tecovirimat for the treatment of human monkeypox virus (HMPXV) disease.

Could this study be right for you?

• Lab-confirmed OR suspected HMPXV infection
• At least one active skin lesion, mouth lesion, or proctitis with or without visible ulcers
• HMPXV illness of <14 days duration prior to study entry

Age Range

18 years and up

Official Title

Safety, Tolerability and Immunogenicity of Recombinant HIV Envelope Protein VRC-HIVRGP096-00-VP (Trimer 4571) vaccine, in HIV-1 Infected Adults on suppressive ART

Purpose

The goal of this research study is to see if an investigational vaccine called Trimer 4571 is safe and well tolerated. Additionally, researchers will see if it will help the immune system produce broadly neutralizing antibodies (bNAbs) against HIV. bNAbs are a type of antibody that can recognize and block many types of HIV from entering healthy cells. Trimer 4571 is a vaccine designed to stimulate the development of bnAbs against HIV.

Could this study be right for you?

• On ART for at least 24 months
• HIV RNA <50 for at least 24 months
• CD4 count ≥200
• Known to have started ART during acute HIV infection
• BMI <40kg/m2

Age Range

18 years and up

Official Title

A Phase I/IIa Randomized, Placebo-Controlled Trial of Conserved-Mosaic T-cell Vaccine in a Regimen with Vesatolimod and Broadly Neutralizing Antibodies in Adults Initiated on Suppressive Antiretroviral Therapy during Acute HIV-1

Purpose

This study will evaluate the safety and efficacy of these treatments in individuals with HIV-1 who started suppressive antiretroviral therapy (ART) during acute HIV-1 infection. The study consists of four steps including an analytical treatment interruption (ATI).

Could this study be right for you?

• Individuals with HIV who started treatment during acute HIV infection
• No known ART interruption >14 consecutive days since ART initiation
• Willingness to participate in analytic treatment interruption
• CD4 count ≥500 within 60 days to study entry
• HIV RNA <50 since initial viral suppression on ART and for at least 1 year prior to study entry

Age Range

18 years and up

Official Title

A Phase I Clinical Trial of the Safety, Tolerability, and Efficacy of IL-15 Superagonist (N-803) With and Without Combination Broadly Neutralizing Antibodies to Induce HIV-1 Control During Analytic Treatment Interruption

Purpose

This study will evaluate the safety, tolerability, and efficacy of N-803 with or without bNAbs, to induce HIV-1 control during an analytic treatment interruption (ATI).

Could this study be right for you?

• HIV RNA <50 for at least 96 weeks
• On a stable ART regimen for at least 96 weeks
• CD4 count above 500
• No known history of CD4 count below 200
• Willingness to participate in analytic treatment interruption (ATI)

Age Range

18 - 70 years

Official Title

Short-term and long-term impact of COVID-19 on multiple sensory systems

Purpose

The purpose of this study is to assess the short-term and long-term impact of COVID-19 on multiple sensory systems, including smell, taste, hearing, and balance.

The study requires about 2.5 hours of your time for your first visit, during which you may undergo smell, taste, hearing, motion, and balance tests. You may be require to participate several follow-up visits, each last 1.5 hours, if you continue to experience symptoms.

 

Could this study be right for you?

• Adults diagnosed with COVID 19 within the past 1-8 weeks
• Adults with previous COVID-19 diagnosis and has persistent (>90 days) complaints of sensory dysfunctions (smell, taste, chemesthesis, hearing, balance, dizziness)
• Adult with a recent (<8 weeks) upper respiratory infection (cold, flu, etc.)
• Adult with a previous upper respiratory infection (cold, flu, etc.) and has complaints of sensory dysfunctions (smell, taste, hearing, balance, dizziness)

Age Range

18 - 99 years

Official Title

Safety, Tolerability, and Outcomes of Velpatasvir/SofosbuviR in Treatment of Chronic Hepatitis C Virus during Pregnancy (STORC), pregnant woman

Purpose

This study involves evaluating a medication for hepatitis C in pregnant women. 

If you are a pregnant woman with chronic hepatitis C and you join the study, you are consenting to enroll yourself and your baby after he/she is born.

Maternal participants will have 7 visits over approximately 7 months. Infant participants have four visits over approximately the first year of life.

Could this study be right for you?

(This is not a complete list)  

- Must be  18 - 45 years of age

- Chronic HCV infection of at least 6 months

- Singleton pregnancy at 20 + 0 to 30 + 0 weeks’ gestation

- Documented negative Hepatitis B testing for current infection (negative HBsAg test) prior to enrollment

- If living with HIV, must be on antiretroviral therapy

 

Exclusion Criteria (not a complete list)

- Plans to relocate away from the study site area in the next 16 months and unable/unwilling to return for study visits

- History of cirrhosis

- Known fetal chromosomal abnormality prior to enrollment

Age Range

18 - 45

Official Title

“Doravirine for Persons with Excessive Weight Gain on Integrase Inhibitors and Tenofovir Alafenamide (The Do IT Study)”

Purpose

The purpose of this study is to see whether people living with HIV who gained a significant amount of weight after starting an antiretroviral therapy (ART) could gain less weight, or might lose weight, after an ART regimen switch. The study will also look at whether a switch in antiretroviral therapy leads to differences in how the body stores and uses energy, heart and blood vessel health, and bone health. The study will last for 48 weeks (about 1 year). Following the first visit, you will need to come back to the clinic after about 4, 12, 24, 36, and 48 weeks. Each visit may take up to 3 hours.

Could this study be right for you?

• Living with HIV-1 • Be 18 years or older • 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 more than 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 • Agree to use contraception/birth control methods if capable of becoming pregnant

Age Range

18 and up

Official Title

A Phase 3, Double-Blind, Multicenter, Randomized Study to Evaluate the Efficacy and Safety of Subcutaneous Twice Yearly Long-Acting Lenacapavir for HIV Pre-Exposure Prophylaxis in Cisgender Men, Transgender Women, Transgender Men, and Gender Non-binary People ≥ 16 Years of Age who Have Sex with Male Partners and are at Risk for HIV InfectionA Phase 3, Double-Blind, Multicenter, Randomized Study to Evaluate the Efficacy and Safety of Subcutaneous Twice Yearly Long-Acting Lenacapavir for HIV Pre-Exposure Prophylaxis in Cisgender Men, Transgender Women, for HIV Pre-Exposure to Those Having Sex with Transgender Men, and Gender Non-binary People ≥ 16 Years of Age who Have Sex with Male Partners and are at Risk for HIV Infection

Purpose

The purpose of this study is to see if Lenacapavir is safe and effective to use as a pre-exposure prevention in Cisgender Men (CGM), Transgender Women (TGW), Transgender Men (TGM) and Gender Non-binary people (GNB), with a high risk of HIV infection.

Could this study be right for you?

• CGM, TGW, TGM, and GNB who have condomless receptive anal sex with partners assigned male at birth and are at risk for HIV infection. • HIV-1 status unknown at screening and no prior HIV-1 testing within the last 3 months • Sexually active with ≥ 1 partner assigned male at birth in the last 12 months and 1 of the following: o Condomless receptive anal sex with ≥ 2 partners in the last 12 weeks o History of syphilis, rectal gonorrhea, or rectal chlamydia in the last 24 weeks o Use of stimulants with sex in the last 12 weeks

Age Range

18 and up