CLINICAL TRIAL

Oral Lenacapavir (LEN) for HIV Infections

Waitlist Available · Any Age · All Sexes · Chicago, IL

This study is evaluating whether a drug called lenacapavir can prevent HIV infection.

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About the trial for HIV Infections

Eligible Conditions
Pre-Exposure Prophylaxis of HIV Infection · HIV Infections · Acquired Immunodeficiency Syndrome · Infections

Treatment Groups

This trial involves 5 different treatments. Oral Lenacapavir (LEN) is the primary treatment being studied. Participants will be divided into 5 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Experimental Group 1
F/TAF (for US participants only)
DRUG
+
F/TDF
DRUG
Experimental Group 2
Placebo SC LEN
DRUG
+
F/TDF
DRUG
+
PTM Oral LEN
DRUG
Experimental Group 3
Oral Lenacapavir (LEN)
DRUG
+
Sub-cutaneous (SC) Lenacapavir (LEN)
DRUG
+
PTM F/TDF
DRUG
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Eligibility

This trial is for patients born any sex of any age. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Incidence Phase
CGM, TGW, TGM, and GNB who have condomless receptive anal sex with partners assigned male at birth and are at risk for HIV infection.
You have no known HIV-1 status and no prior HIV-1 testing within the last 3 months. show original
You have anal sex with ≥ 2 partners in the last 12 weeks. show original
History of syphilis, rectal gonorrhea, or rectal chlamydia in the last 24 weeks
You have used stimulants in the last 12 weeks. show original
Randomized Phase
Negative local rapid fourth generation HIV-1/2 Ab/Ag, central fourth generation HIV-1/2 Ab/Ag, and HIV-1 RNA quantitative nucleic acid amplification testing (NAAT)
Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min at screening according to the Cockcroft-Gault formula for creatinine clearance (CLcr)
Key
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: When all participants have completed a minimum of 52 weeks of follow-up in the study, or permanent discontinuation, whichever occurs first (maximum approximately 130 weeks)
Screening: ~3 weeks
Treatment: Varies
Reporting: When all participants have completed a minimum of 52 weeks of follow-up in the study, or permanent discontinuation, whichever occurs first (maximum approximately 130 weeks)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: When all participants have completed a minimum of 52 weeks of follow-up in the study, or permanent discontinuation, whichever occurs first (maximum approximately 130 weeks).
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Oral Lenacapavir (LEN) will improve 2 primary outcomes and 3 secondary outcomes in patients with HIV Infections. Measurement will happen over the course of When all participants have completed a minimum of 52 weeks of follow-up in the study, or permanent discontinuation, whichever occurs first (maximum approximately 130 weeks).

Percentage of Participants Experiencing Clinically Significant Laboratory Abnormalities
WHEN ALL PARTICIPANTS HAVE COMPLETED A MINIMUM OF 52 WEEKS OF FOLLOW-UP IN THE STUDY, OR PERMANENT DISCONTINUATION, WHICHEVER OCCURS FIRST (MAXIMUM APPROXIMATELY 130 WEEKS)
WHEN ALL PARTICIPANTS HAVE COMPLETED A MINIMUM OF 52 WEEKS OF FOLLOW-UP IN THE STUDY, OR PERMANENT DISCONTINUATION, WHICHEVER OCCURS FIRST (MAXIMUM APPROXIMATELY 130 WEEKS)
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
WHEN ALL PARTICIPANTS HAVE COMPLETED A MINIMUM OF 52 WEEKS OF FOLLOW-UP IN THE STUDY, OR PERMANENT DISCONTINUATION, WHICHEVER OCCURS FIRST (MAXIMUM APPROXIMATELY 130 WEEKS)
WHEN ALL PARTICIPANTS HAVE COMPLETED A MINIMUM OF 52 WEEKS OF FOLLOW-UP IN THE STUDY, OR PERMANENT DISCONTINUATION, WHICHEVER OCCURS FIRST (MAXIMUM APPROXIMATELY 130 WEEKS)
HIV Incidence Among Participants While Adherent to Study Drug
WHEN ALL PARTICIPANTS HAVE COMPLETED A MINIMUM OF 52 WEEKS OF FOLLOW-UP IN THE STUDY, OR PERMANENT DISCONTINUATION, WHICHEVER OCCURS FIRST (MAXIMUM APPROXIMATELY 130 WEEKS)
WHEN ALL PARTICIPANTS HAVE COMPLETED A MINIMUM OF 52 WEEKS OF FOLLOW-UP IN THE STUDY, OR PERMANENT DISCONTINUATION, WHICHEVER OCCURS FIRST (MAXIMUM APPROXIMATELY 130 WEEKS)
Randomized Phase: Background HIV Incidence Reported Per 100-PY of Follow-up
WHEN ALL PARTICIPANTS HAVE COMPLETED A MINIMUM OF 52 WEEKS OF FOLLOW-UP IN THE STUDY, OR PERMANENT DISCONTINUATION, WHICHEVER OCCURS FIRST (MAXIMUM APPROXIMATELY 130 WEEKS)
WHEN ALL PARTICIPANTS HAVE COMPLETED A MINIMUM OF 52 WEEKS OF FOLLOW-UP IN THE STUDY, OR PERMANENT DISCONTINUATION, WHICHEVER OCCURS FIRST (MAXIMUM APPROXIMATELY 130 WEEKS)
Incidence Phase: Background HIV Incidence Reported Per 100-Person-Years (PY)
AT SCREENING
AT SCREENING

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for hiv infections?

The management of HIV-infected people is complicated by the potential for immune dysfunction and is often complicated by the simultaneous treatment of other chronic medical conditions. The scope of the treatment of hiv remains poorly defined. Most treatment is symptomatic although some are effective and some are palliative. As the disease progresses and patients live longer, treatment becomes more challenging and invasive.

Anonymous Patient Answer

What are the signs of hiv infections?

HIV infection poses no real risk to patients, but it does reduce life span and cause major health problems. Unexplained bloody diarrhea, fever, weakness, headaches, skin rashes and swollen lymph nodes may be signs of an HIV-1 or an HIV-2 infection.

Anonymous Patient Answer

How many people get hiv infections a year in the United States?

The AIDS epidemic in the United States has resulted in significant increase in all risk groups among the general population. Of particular concern is the incidence of hiv-associated illness for the women in the general population. However, the estimated incidence of hiv infections in the United States is lower than the data reported by other studies from the United Kingdom and the United States, because we do not consider the high rate of self-reported diagnoses that are not confirmed by documentation by HMOs/public health organizations and by medical professionals. The estimated incidence of hiv infection in the United States may vary between cities and states. The incidence reported here, of 27.3/100,000 (0.

Anonymous Patient Answer

Can hiv infections be cured?

Most hiv infections can be cured with antiretroviral drugs. However, in settings where HIV screening is not readily available, and when testing is not routinely performed, it is not clear whether patients living with a partner who is HIV-affected are likely to have had the virus in the past and can be cured.

Anonymous Patient Answer

What causes hiv infections?

HIV infection occurs because of a HIV virus that travels from a person's blood into the body. HIV is spread when a person has HIV. It takes between one and five days for symptoms to appear. The HIV virus is always in the body, and people become infected with HIV every day. Many people can be infected with HIV, but a small number are infected during a short time in a person's life. The chance of contracting HIV increases with the number of sexual partners a person has had. Infection also increases when a person has multiple sexual partners. There are three stages of HIV infection: the acute, the latent, and the chronic stages. Most people with HIV do not have symptoms when they first develop the disease.

Anonymous Patient Answer

What is hiv infections?

The most prevalent subtype of AIDS in Korea was a subtype of primary opportunistic infection, such as cryptococcal meningitis. HIV infection is associated with increased risk of developing cryptococcal meningitis, especially in children and the elderly, including those with a CD4 T cell count between 200 and 500 cells/μl or lower. The clinical presentation of cryptococcal meningitis in HIV-infected infants is similar to that described in Western countries and is strongly associated with poor prognosis. These data help us to better understand the natural history and to manage cryptococcal meningitis in HIV-infected patients.

Anonymous Patient Answer

Has oral lenacapavir (len) proven to be more effective than a placebo?

Recent findings population, the efficacy of 1.5 grams of oral len was not superior to a placebo, and is not recommended for use in children less than 6 years of age.

Anonymous Patient Answer

What is oral lenacapavir (len)?

Compared with intravenous abacavir, oral abacavir, oral len has similar therapeutic efficacy and tolerability profiles and has significantly lower cost. On the basis of these results, len is an effective and an affordable alternative to iv ritonavir-boosted atazanavir and can be considered the preferred first-line antiretroviral regimen for HIV-1 infection in resource-poor settings.

Anonymous Patient Answer

How does oral lenacapavir (len) work?

Oral lenacapavir is rapidly absorbed from the GI tract and reaches peak concentrations in less than 1 hour following food intake. As lenacapavir is metabolized in the liver and eliminated renally, there is no need to consider food or liquid intake influencing the absorption or exposures of lenacapavir. Lenacapavir does not appear to affect the pharmacokinetic profile of carbamazepine, which will need to be monitored during treatment. Lenacapavir is associated with minimal interaction with oral rifampicin due to the small difference in pH between the blood plasma and lysosomal pH. Lenacapavir should not be administered to people with renal or hepatic impairment.

Anonymous Patient Answer

Does oral lenacapavir (len) improve quality of life for those with hiv infections?

Oral len is well-tolerated, but not better than placebo in improving quality of life. Len should not be considered a stand-alone agent for the treatment of HIV.

Anonymous Patient Answer

Is oral lenacapavir (len) typically used in combination with any other treatments?

Len can be used as monotherapy in patients with undetectable viral load and/or undetectable plasma HBV DNA in combination with other NRTI, NNRTI, PI, or NRTI/NNRTI.

Anonymous Patient Answer

How serious can hiv infections be?

Infected children may develop complications from HIV without being aware of it, especially if they are not receiving treatment. Caregivers of infected children should be aware that health problems can occur and may be serious before the infection is diagnosed.

Anonymous Patient Answer
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