Is NCT07672717 recruiting in Baltimore, MD?

Yes, NCT07672717 is currently recruiting participants at its Baltimore, MD location. This hiv clinical trial is actively enrolling qualified participants.

How do I join the hiv clinical trial in Baltimore?

To join this clinical trial in Baltimore, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Baltimore clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

HIV Clinical Trial in Baltimore, MD

About This HIV Study in Baltimore

This is a research study to better understand how long-acting cabotegravir (CAB-LA) works to prevent HIV in people. This study will also evaluate the impact of endogenous and therapeutic hormones on CAB-LA pharmacology. The investigators will also evaluate if participants experience any medical problems when taking CAB-LA.

Sponsor: Johns Hopkins University

Who Can Participate

Inclusion Criteria

19 years of age or older

For persons using exogenous hormones, must be on a stable regimen for ≥6 months and remain on that regimen throughout study conduct, and exogenous hormone regimens must be prescribed and managed under the care of a healthcare professional

For females, must be on a non-hormonal contraceptive agent, and must persist in contraceptive use for the duration of the study

Body weight greater than 35 kg (77.2 lbs)

HIV-1 uninfected at screening and enrollment as documented by an instrumented Ag/Ab assay and HIV-1 RNA testing

Understand and agree to local STI reporting requirements

Willing to abstain from additional antiretroviral agents (including PrEP agents, F/TAF and F/TDF) during the duration of the study

Willing to abstain from insertion of anything (drug, enema, penis, or sex toy) in the rectum or vagina for 72 hours before and 72 hours after each flexible sigmoidoscopy

Willing to refrain from aspirin and NSAID use for one week before and after each study biopsy visit

Willing and able to use condoms for all receptive anal intercourse and receptive vaginal intercourse for the duration of study participation

Able and willing to communicate in English

Able and willing to provide written informed consent to take part in the study

Able and willing to provide adequate information for locator purposes

Availability to return for all study visits, barring unforeseen circumstances

Agree not to participate in other research studies involving drugs and/or medical devices for the duration of the study

Exclusion Criteria

History of previous long-acting antiretroviral use, including CAB-LA and long-acting lenacapavir

History of oral PrEP (F/TDF, F/TAF) use within the prior eight weeks

For females, if a participant is pregnant or plans to become pregnant during study duration

For females, if the participant is actively breastfeeding

For females, if the participant is post-menopausal or accessing exogenous hormone replacement therapy

For females, has irregular menstrual cycles

Has a tattoo or other dermatological condition which may interfere with product administration or interpretation of injection site reactions

Surgically-placed or injected buttock implants or filler, per self-report

One or more reactive or positive HIV test results at screening or enrollment, even if HIV infection is not confirmed

Current known HIV-infected partner(s)

Symptoms suggestive of acute HIV seroconversion at screening and enrollment

Known or suspected allergy to CAB-LA

Any ≥ Grade 2 laboratory abnormality at baseline as defined by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 - July 2017, and Addendum 3 (Rectal Grading Tables for Use in Microbicide Studies)

Significant rectal symptom(s) as determined by medical history or by participant self-report (including but not limited to presence of any unresolved injury, infectious or inflammatory condition of the local mucosa, history of inflammatory bowel disease, presence of symptomatic hemorrhoids, and presence of any painful anorectal conditions that would be tender to manipulation)

At screening or within the past 2 months: participant-reported symptoms and/or clinical or laboratory diagnosis of active rectal or genital infection requiring treatment per current CDC guidelines or symptomatic urinary tract infection (UTI). Infections requiring treatment include chlamydia (CT), gonorrhea (GC), syphilis, active HSV lesions, chancroid, genital sores or ulcers, and, if clinically indicated, genital warts. HSV seropositivity with no active genital lesions is not an exclusion criterion. (Note: if an STI apart from HIV is detected, the participant will be referred for treatment and can be retested in 30 days and re-screened once.)

History of significant gastrointestinal bleeding

Clinically significant cardiovascular disease, as defined by history of symptomatic arrhythmia, ischemia, or other significant cardiac disease

Current use of warfarin or heparin or other anticoagulant medications associated with increased risk for bleeding following mucosal biopsy (e.g., daily high dose aspirin \[\>81 mg\], NSAIDs, or Pradaxa®)

Use of systemic or anorectal immunomodulatory medications within 4 weeks of enrollment or planned use at any time during study participation

Per participant report, use of any rectally or vaginally administered products containing N-9 (including condoms) or investigational products within 4 weeks of enrollment, or planned use of either at any time during study participation

Any other condition or prior therapy that, in the opinion of the investigator, would preclude informed consent, make study participation unsafe, make the individual unsuitable for the study or unable to comply with the study requirements.

Individuals with neocervix will be excluded from giving cervical biopsies, if eligible for study participation.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Baltimore?

Yes, this clinical trial (NCT07672717) has an active research site in Baltimore, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

HIV Treatment Options in Baltimore, MD

If you're searching for hiv treatment options in Baltimore, MD, this clinical trial (NCT07672717) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Baltimore research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced hiv specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all hiv clinical trials near you to find additional studies recruiting in your area.

HIV Clinical Trial in Baltimore, MD

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