What side effects are associated with this type of intervention?

Common treatments for HIV/AIDS, such as protease inhibitors (e.g., TMC310911 coadministered with ritonavir) and integrase inhibitors (e.g., dolutegravir), often have side effects including fatigue, nausea, and diarrhea. Serious adverse events are rare but can include skin reactions like Stevens-Johnson syndrome and neuropsychiatric events. Inappropriate dosing and drug-drug interactions are also notable concerns. Overall, while these treatments are effective in reducing HIV-1 RNA levels, patients should be monitored for these potential side effects.

What prior FDA approvals exist?

The FDA has approved numerous antiretroviral drugs for the treatment of HIV/AIDS, which are typically used in combination to manage the virus effectively. These include nucleoside reverse transcriptase inhibitors (NRTIs) like zidovudine and lamivudine, non-nucleoside reverse transcriptase inhibitors (NNRTIs) such as efavirenz, protease inhibitors (PIs) like ritonavir, and integrase strand transfer inhibitors (INSTIs) such as raltegravir. Additionally, newer classes like entry inhibitors and pharmacokinetic enhancers have been approved. These treatments work by inhibiting various stages of the HIV life cycle, thereby reducing viral load and improving immune function. MK-8527, being studied as a preventive agent, aligns with the ongoing efforts to expand HIV prevention strategies beyond treatment.

What other types of research exist?

Promising novel alternatives to MK-8527 for HIV/AIDS patients include GSK-1349572 (an integrase inhibitor), VS-411 (an NRTI-based antiviral), MK-0518 (an integrase strand transfer inhibitor), MK-8507 (a nonnucleoside reverse transcriptase inhibitor), and MK-8591 (a reverse transcriptase-translocation inhibitor). These drugs are in various stages of clinical trials and have shown potential in preclinical or early clinical studies.

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Antiretroviral Agent

MK-8527 for HIV Prevention

Phase 2

Waitlist Available

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1: predose and 0.5, 4, and 24 hours postdose. week 20: 0.5, 4, and 24 hours postdose

Awards & highlights

Summary

This trial tests a pill called MK-8527 in people who are unlikely to get HIV-1 to see if it is safe and how their bodies handle it.

Who is the study for?

This trial is for individuals at low risk of HIV-1 infection who have tested negative for HIV. Men must use contraception or abstain from penile-vaginal intercourse if they can produce sperm, and women should not be pregnant, breastfeeding, and must either use effective contraception or abstain if they are capable of childbearing.

What is being tested?

The study is testing the safety and how the body processes a once-monthly oral pill called MK-8527 compared to a placebo (a pill with no active drug) in people at low risk for HIV-1. Participants won't know whether they're getting MK-8527 or the placebo.

What are the potential side effects?

Potential side effects of MK-8527 aren't detailed here but typically include reactions where pills are processed in the body such as stomach issues, potential allergic reactions, or other symptoms that will be closely monitored.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1: predose and 0.5, 4, and 24 hours postdose. week 20: 0.5, 4, and 24 hours postdose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1: predose and 0.5, 4, and 24 hours postdose. week 20: 0.5, 4, and 24 hours postdose

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1: predose and 0.5, 4, and 24 hours postdose. week 20: 0.5, 4, and 24 hours postdose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants Discontinuing From Study Therapy Due to AE

Number of Participants With ≥1 Adverse Event (AE)

Secondary study objectives

Area Under the Plasma Concentration-Time Curve From Dosing to Last Measurable Concentration (AUC0-last) of MK-8527

Maximum Plasma Concentration (Cmax) of MK-8527

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: MK-8527 Medium Dose QMExperimental Treatment1 Intervention

Participants receive oral MK-8527 medium dose QM for 6 months, followed by an 8-week blinded safety follow-up period.

Group II: MK-8527 Low Dose QMExperimental Treatment1 Intervention

Participants receive oral MK-8527 low dose QM for 6 months, followed by an 8-week blinded safety follow-up period.

Group III: MK-8527 High Dose QMExperimental Treatment1 Intervention

Participants receive oral MK-8527 high dose QM for 6 months, followed by an 8-week blinded safety follow-up period.

Group IV: Placebo to MK-8527Placebo Group1 Intervention

Participants receive oral placebo matched to MK-8527 QM for 6 months, followed by an 8-week blinded safety follow-up period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MK-8527

2019

Completed Phase 1

~40

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for HIV/AIDS, known as antiretroviral therapy (ART), involve a combination of drugs that target different stages of the HIV life cycle. Nucleoside reverse transcriptase inhibitors (NRTIs) and non-nucleoside reverse transcriptase inhibitors (NNRTIs) block the reverse transcriptase enzyme, preventing the conversion of viral RNA into DNA. Protease inhibitors (PIs) inhibit the protease enzyme, which is crucial for the maturation of infectious viral particles. Integrase strand transfer inhibitors (INSTIs) prevent the integration of viral DNA into the host genome, and entry inhibitors block the virus from entering host cells. These mechanisms are vital for reducing viral load, improving immune function, and preventing the progression to AIDS. Investigational agents like MK-8527, which are being studied for their potential to prevent HIV-1 infection, represent a promising advancement in the effort to control and eventually eradicate HIV.

IAS Towards an HIV Cure Symposium: people focused, science driven: 18-19 July 2015, Vancouver, Canada.COMMENTARY: understanding the benefits of pediatric anti-retroviral treatment in resource-limited settings.Optimal time for initiation of antiretroviral therapy in asymptomatic, HIV-infected, treatment-naive adults.

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Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor

3,950 Previous Clinical Trials

5,174,633 Total Patients Enrolled

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,834 Previous Clinical Trials

8,079,430 Total Patients Enrolled

~58 spots leftby Dec 2024

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