18F-Raltegravir Distribution for HIV

Overseen By Timothy J Henrich, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of California, San Francisco

Must be taking: Antiretrovirals

Must not be taking: Immunomodulatory drugs

Disqualifiers: Serious illness, Pregnancy, Pacemaker, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how a special form of the drug raltegravir (an antiretroviral medication) moves through the body in people with HIV. Researchers use a tiny dose marked with a safe tracer to track its path via imaging scans. The trial is open to individuals with HIV who are already on a treatment plan that includes raltegravir. Participants will observe how the medication reaches different parts of their body, potentially aiding in the improvement of future HIV treatments. As an Early Phase 1 trial, this research aims to understand how this form of raltegravir works in people, offering participants a unique opportunity to contribute to the foundational knowledge of HIV treatment.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but it does mention that you cannot be on immunomodulatory drugs. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that raltegravir, when combined with other HIV medications, is generally well-tolerated by patients. Studies have found that it effectively controls the HIV virus and is safe for long-term use. For instance, one study found that after 96 weeks, the treatment remained effective and safe for patients.

Raltegravir is widely used and approved by the FDA for treating HIV in both adults and children. However, some studies have reported that a small number of patients experienced serious skin reactions. These reactions are rare but important to know about.

In this trial, researchers are testing a very small dose of a special form of raltegravir (18F-raltegravir). This tiny dose is used to observe how the drug moves through the body. Because the dose is so low, the risk of side effects is likely smaller compared to the regular doses used for treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about 18F-Raltegravir because it offers a unique approach to understanding HIV treatment. While traditional treatments for HIV focus on suppressing viral replication with antiretroviral drugs, 18F-Raltegravir uses a radiolabeled form of raltegravir to visualize how the drug is distributed in the body. This innovative method could provide valuable insights into how HIV therapies interact with tissues, potentially leading to more effective treatment strategies. By mapping the distribution of raltegravir, scientists hope to optimize dosing and enhance therapeutic outcomes for patients living with HIV.

What evidence suggests that 18F-Raltegravir is effective for HIV?

Research has shown that raltegravir, when combined with other HIV treatments, can effectively control HIV-1, the virus that causes AIDS. In some studies, up to 79% of patients had no detectable HIV in their blood after using raltegravir with other medications for 96 weeks. Most people tolerate it well, experiencing no serious side effects. Raltegravir blocks a protein that HIV needs to multiply, making it a powerful tool for controlling the virus and helping the immune system stay healthy. Participants in this trial will receive 18F-Raltegravir, an experimental form of the drug, to study its distribution in the body. ^{1 3 5 6 7}

Who Is on the Research Team?

Timothy J Henrich, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults over 18 with HIV who are on ART regimens. They must have normal levels of neutrophils, platelets, hemoglobin, and liver enzymes, and not be severely ill or hospitalized recently. Pregnant or breastfeeding women can't join, nor those with certain metal implants incompatible with MRI.

Inclusion Criteria

HIV infection

You have started a combination therapy for HIV/AIDS treatment.

Exclusion Criteria

Screening absolute neutrophil count <1,000 cells/mm3

Screening platelet count <70,000 cells/mm3

Screening hemoglobin < 8 mg/dL

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single microdose of 18F-raltegravir and undergo PET/MRI to determine drug distribution

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Raltegravir

Trial Overview The study tests how a microdose of the drug 18F-raltegravir spreads through the body in HIV patients using PET/MRI scans. It aims to understand the drug's distribution in tissues, especially within the lymphoreticular system.

How Is the Trial Designed?

Group I: 18F-Raltegravir Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6075661/

Long-Term Efficacy and Safety of the HIV Integrase ... Raltegravir in combination therapy has demonstrated potent suppression of HIV-1 with a favorable safety profile. This report provides 96-week efficacy and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01213316

A Study to Assess the Efficacy of Raltegravir (Isentress® ... This is an observational, non-comparative, multicenter, open-label study. Participants will be treated with Raltegravir according to standard clinical practice.

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa0708975

Raltegravir with Optimized Background Therapy for ... Without adjustment for the length of follow-up, cancers were detected in 3.5% of raltegravir recipients and in 1.7% of placebo recipients. The overall ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6076431/

Week 96 Results of the BENCHMRK 1 and 2 Phase III Trials Among patients who received new, active antiretroviral therapy in their OBT, up to 79% of raltegravir recipients had undetectable HIV RNA levels at week 96.

5. merck.com merck.com/news/merck-announces-week-96-results-from-oncemrk-a-study-evaluating-once-daily-isentress-hd-raltegravir-in-combination-with-other-antiretroviral-agents-for-the-treatment-of-hiv-1-infection-in-a/

Merck Announces Week 96 Results from ONCEMRK, A ... Increases in CD4+T-cell counts from baseline were comparable for the two treatment regimens, with an average increase of 261.6 cells/mm3 for once-daily ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT00485264

Safety and Pharmacokinetics (PK) of Raltegravir in HIV ... The results present safety and efficacy results of the complete 5 year follow up data (primary and key secondary endpoints) of the participants from IMPAACT ...

7. clinicalinfo.hiv.gov clinicalinfo.hiv.gov/en/guidelines/perinatal/safety-toxicity-arv-agents-integrase-inhibitors-raltegravir-isentress

Raltegravir (Isentress, Isentress HD) - Safety and Toxicity in ... Risk of birth defects and perinatal outcomes in HIV-infected women exposed to integrase strand inhibitors during pregnancy. AIDS. 2021;35(2):219-226 ...