Antiviral Therapy

Researchers are evaluating new medicines to prevent HIV-1 Human Immunodeficiency Virus Type 1 infection. This Phase 3 clinical study aims to determine if taking the drug MK-8527 once a month can prevent HIV-1 infection as well as or better than the standard daily pre-exposure prophylaxis PrEP. The study also assesses the safety and tolerance of MK-8527 in participants. Participants are randomly assigned to one of two groups. One group receives 11 mg of MK-8527 once monthly along with a daily placebo pill matching FTCTDF. The other group receives a daily dose of FTC245 mg TDF and a monthly placebo matching MK-8527. This treatment period lasts for approximately two years, followed by an additional 28-day period where all participants receive open-label FTCTDF daily. During the study, participants will undergo regular monitoring to check for HIV-1 infection and any adverse events. Researchers will track the number of participants who acquire HIV-1, experience side effects, or stop treatment due to side effects over the two-year period. Safety and adherence assessments will be conducted to evaluate the study treatments. The total participation time includes the two-year treatment phase plus the 28-day follow-up with open-label FTCTDF.

Researchers are evaluating a multilevel trauma-informed approach to increase HIV pre-exposure prophylaxis PrEP initiation among Black cisgender women in Baltimore, who are considered a high-risk group for HIV. This study aims to address socio-structural challenges such as intimate partner violence and gendered racism that may limit access to PrEP, focusing on both women with and without experiences of intimate partner violence. The research is sponsored by the Johns Hopkins Bloomberg School of Public Health and involves a randomized design without masking. Participants will be randomly assigned to one of two groups. The intervention group will receive behavioral lifestyle education related to biomedical HIV prevention, consisting of four weekly group sessions and four individual sessions with a peer navigator. The control group will receive a single group session. These sessions aim to increase understanding and uptake of PrEP among eligible Black women. During the study, researchers will monitor PrEP initiation up to six months after baseline and assess adherence at two, four, and six months post-randomization. Participant involvement includes attending scheduled educational sessions and follow-up assessments. The study will track how well participants start and continue PrEP use, with safety and sustainability of the intervention also evaluated. The total study duration extends through February 2028.

Researchers are evaluating new medicines to prevent infection with Human Immunodeficiency Virus Type 1 HIV-1. This Phase 3 clinical trial aims to find out if taking MK-8527 once a month is more effective than a daily standard pre-exposure prophylaxis PrEP in preventing HIV-1 infection in women. The study also monitors the safety and tolerability of MK-8527 compared to standard treatment. Participants are randomly assigned to one of two groups one group receives 11 mg of MK-8527 once monthly along with a placebo daily pill resembling EmtricitabineTenofovir Disoproxil Fumarate FTCTDF, and the other group receives the daily FTCTDF pill plus a monthly placebo resembling MK-8527. This treatment phase lasts for up to approximately two years. Afterward, all participants take open-label FTCTDF daily for an additional 28 days. During the study, participants attend regular visits for up to about two years, during which researchers check for new HIV-1 infections, record any adverse events or side effects, and monitor if participants stop the study medication due to side effects. The primary outcomes include the number of participants who acquire HIV-1 infection, those who experience adverse events, and those who discontinue due to adverse events, all tracked over the treatment period.

This research aims to evaluate the added effect of Amantadine or Duloxetine when combined with Pregabalin on the development of post mastectomy pain syndrome PMPS, a common chronic pain condition occurring after breast surgery. PMPS affects 20% to 50% of patients and is a type of chronic post-surgical pain. The study investigates how these medications might influence pain pathways and nerve excitability in patients undergoing modified radical mastectomy for breast cancer. Participants are assigned randomly to one of three groups. Two hours before surgery, one group receives Pregabalin 75 mg with a placebo tablet another group receives Pregabalin 75 mg plus Amantadine 100 mg and the third group receives Pregabalin 75 mg plus Duloxetine 30 mg. All treatments are continued twice daily for seven days after surgery. This double-blind study compares the effect of these treatments on pain development following mastectomy. During the study, researchers will monitor the occurrence of post mastectomy pain syndrome 12 weeks after surgery as the primary outcome. Secondary outcomes include patient quality of life, activity level, pain severity at 12 weeks, and opioid use during and after surgery. Side effects related to each medication are tracked for 48 hours post-procedure. Participants are evaluated through clinical assessments and medication monitoring over the course of the treatment and follow-up period.

Researchers are evaluating the safety and effectiveness of low-dose Apixaban combined with standard medical therapy compared to standard therapy alone to prevent left ventricular LV thrombus formation after primary PCI in patients with acute anterior myocardial infarction and severe LV dysfunction. This open-label, randomized controlled trial focuses on patients aged 18 to 65 years with an ejection fraction below 35% and specific heart motion abnormalities. Participants will be randomly assigned to receive either Apixaban 2.5 mg twice daily plus dual antiplatelet therapy aspirin and clopidogrel for four weeks along with guideline-directed medical therapy, or guideline-directed medical therapy alone including dual antiplatelet therapy. After four weeks, those in the Apixaban group will continue with dual antiplatelet therapy. In case of stent thrombosis, some medication adjustments may be made. Follow-up includes phone assessments at two weeks and an in-person visit with echocardiography at four weeks. During the study, participants will be monitored for LV thrombus formation using echocardiography at four weeks, and clinical status, medication side effects, and adherence will be assessed. The primary outcome is the incidence of LV thrombus formation at one month. Secondary measures include rates of death, recurrent heart attacks, stent thrombosis, heart failure hospitalizations, bleeding events, and drug discontinuation due to side effects. Safety and outcomes will be independently reviewed by a clinical events committee.

This research aims to understand patient and physician perspectives on offering medications known as pre-exposure prophylaxis PrEP to prevent HIV transmission in a family planning clinic. The study focuses on whether patients find it acceptable to be asked about and offered PrEP during their visits, and explores the factors that make it easier or harder to discuss and begin PrEP in this clinical setting. The study is a pilot designed to gather data on feasibility and acceptability to help expand PrEP services in such clinics. Participants include patients who will receive standardized counseling about PrEP and have the option to start PrEP as part of their usual care. Physicians will receive standardized training on PrEP screening and initiation protocols and will support patients interested in starting PrEP. Both patients and physicians will complete surveys about their experiences, and a subgroup of physicians may also participate in in-depth interviews. The study does not include a control group and integrates into routine family planning care. Participants will be approached by a research assistant for consent and receive a 25 gift card after completing a post-intervention survey. Physicians complete pre- and post-study surveys and possibly interviews. The study measures acceptability, feasibility, and appropriateness of the intervention up to 6 hours for patients and up to 12 months for physicians. The study runs from May 2026 to December 2026, focusing on integrating PrEP screening and initiation into clinical workflow and understanding barriers and facilitators from both patients and providers.

Researchers are evaluating how long-acting cabotegravir CAB-LA works to prevent HIV in adults aged 19 years or older. This phase 1, open-label study also examines how natural and therapeutic hormones affect the drugs behavior in the body. The study focuses on measuring drug levels directly in blood, rectal and genital tissues, and secretions to better understand CAB-LAs pharmacology, especially at sites where HIV transmission occurs. Participants will receive a single 600 mg intramuscular injection of CAB-LA using the FDA-approved method. The study includes three groups males not using hormones, males on hormone therapy, and females using non-hormonal contraception. Over about 12 weeks, participants will have multiple visits for biopsies, blood draws, and fluid collections to measure CAB-LA concentrations and hormone levels, as well as to assess tissue susceptibility to HIV before and after drug exposure. Participants will undergo screening and a baseline visit with evaluations including HIV tests and hormone measurements. During the study, they will attend several visits for biopsies, blood tests, and safety monitoring, including medication logs to track hormone use. Researchers will measure plasma and tissue drug levels, hormone concentrations, and HIV tissue response over 12 weeks. The study aims to understand drug interactions and safety while participants receive the injectable medication and complete all scheduled assessments.

This research aims to evaluate the impact of dyadic, focused case management on improving financial wellbeing, access to food, and HIV care outcomes for people living with or vulnerable to HIV. The study includes men who have sex with men, gender-diverse persons, and cis-gender women at increased risk or living with HIV. Researchers will compare this approach to routine Ryan White Non-Medical Case Management to see if it leads to better care retention and viral suppression. Participants will be randomly assigned to one of two groups. One group receives the usual Ryan White Non-Medical Case Management, which is client-initiated and focused on needs. The other group receives dyadic case management, where two case managers work together with the participant focusing on goal setting, future planning, and financial stability using techniques like Appreciative Inquiry. Throughout the 18-month study period, participants will be monitored for changes in financial wellbeing and food security as primary outcomes. Secondary outcomes include persistence with PrEP treatment and rates of viral suppression among those living with HIV. Researchers will track these measures to assess how the interventions affect participants health and wellbeing over time.

Researchers are evaluating the impact of unconditional cash transfers on mental bandwidth, antiretroviral therapy ART adherence, and postpartum retention among pregnant women with HIV in Botswana. This pilot trial explores if providing monthly cash support improves these outcomes compared to usual care, while also assessing the feasibility and acceptability of delivering cash transfers via mobile money at public antenatal clinics. The study addresses the challenge of poverty as a barrier to sustained ART engagement during pregnancy and postpartum periods. Participants are pregnant women with HIV in their second trimester, randomly assigned to either receive the usual care plus a monthly unconditional cash transfer of 1,000 Botswana Pula BWP through six months postpartum or usual care alone. The study enrolls 100 women, with 50 in each group. Study visits occur at baseline, late pregnancy before delivery, and 3 to 6 months postpartum, including surveys, bandwidth assessments, and clinical data collection. A subset of participants will be interviewed qualitatively to explore intervention feasibility and acceptability. During the study, participants complete questionnaires and mental bandwidth tests at three key time points baseline, late pregnancy, and postpartum. Researchers will measure ART adherence from baseline through six months postpartum and evaluate food security, psychological distress, and other related outcomes. Safety and acceptability are monitored through interviews conducted 3 to 8 months postpartum. The entire participation spans from the second trimester through six months after delivery, with data collected at three visits.

This research aims to evaluate the use of high concentration 2% Ganciclovir Eye Drops in treating cytomegalovirus retinitis, a serious eye infection. The study is a single-center, prospective trial where patients diagnosed with this condition are carefully monitored. The study follows ethical guidelines, and participants provide informed consent after being fully informed about the treatment and potential risks. Participants receive 2% Ganciclovir Eye Drops with a specific dosing schedule 10 times per day for the first two weeks, then 8 times per day for the following two weeks, 6 times per day for the next two weeks, and finally 4 times per day for more than six weeks. The study focuses on one experimental group using this eye drop therapy. Throughout the study, researchers assess various eye health measures including visual acuity, eye pressure, corneal condition, inflammation, optical coherence tomography, and wide-angle fundus imaging. The main outcome measured is the condition of fundus lesions over 24 weeks, along with changes in best corrected visual acuity. Safety and effectiveness are monitored during this period, with the total participation lasting up to 24 weeks.