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Nucleoside Reverse Transcriptase Inhibitor
Islatravir + Lenacapavir for HIV
Phase 2
Waitlist Available
Research Sponsored by Gilead Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented plasma human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) < 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL) for ≥ 24 weeks before and at screening
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will study whether a combination of two drugs, islatravir and lenacapavir, is effective in suppressing HIV in people who are already virologically suppressed.
Who is the study for?
This trial is for people with HIV who have maintained a viral load of less than 50 copies/mL and have been on B/F/TAF treatment for at least 24 weeks. They shouldn't have had previous virologic failures, exposure to ISL or LEN, serious infections within the last month, hepatitis B or C co-infections, low kidney function or certain low blood cell counts.Check my eligibility
What is being tested?
The study tests the effectiveness of taking Islatravir (ISL) orally once a week combined with Lenacapavir (LEN) in those whose HIV is already under control. The goal is to see how well this combination works after 24 weeks compared to their current treatment.See study design
What are the potential side effects?
While specific side effects are not listed here, common side effects from HIV treatments like ISL and LEN may include nausea, headache, fatigue, and potential liver issues. Side effects can vary based on individual health conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My HIV-1 levels have been undetectable or very low for at least 24 weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 24 as Determined by the US Food and Drug Administration (FDA)-defined Snapshot Algorithm
Secondary outcome measures
Change From Baseline in CD4+ Cell Count at Week 24
Change From Baseline in CD4+ Cell Count at Week 48
Change From Baseline in Clusters of Differentiation 4 (CD4)+ Cell Count at Week 12
+11 moreSide effects data
From 2023 Phase 3 trial • 35 Patients • NCT0423321629%
Diarrhoea
21%
Lymphocyte count decreased
21%
COVID-19
21%
Creatinine renal clearance decreased
14%
Fatigue
14%
Headache
14%
Nausea
14%
Accidental overdose
14%
Rash
7%
Intermittent claudication
7%
Oropharyngeal pain
7%
Hypertension
7%
Humerus fracture
7%
Alanine aminotransferase increased
7%
Motor dysfunction
7%
Proteinuria
7%
Sleep terror
7%
Haematuria
7%
Arthralgia
7%
C-reactive protein increased
7%
Postoperative wound infection
7%
Urinary tract infection
7%
Pancytopenia
7%
Memory impairment
7%
Dry eye
7%
Intestinal transit time increased
7%
Eye irritation
7%
Skin candida
7%
Upper respiratory tract infection
7%
Obesity
7%
Anaemia
7%
Chest pain
7%
Exposure to communicable disease
7%
Abdominal pain
7%
Mitral valve incompetence
7%
Pyrexia
7%
Blood creatine phosphokinase increased
7%
Amoebiasis
7%
Blood calcium increased
7%
Anaemia postoperative
7%
Blood cholesterol increased
7%
Respiratory tract infection viral
7%
Device dislocation
7%
Blood glucose increased
7%
Myelopathy
7%
Cough
7%
Night sweats
7%
Peripheral arterial occlusive disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
DOR+ART
DOR/ISL+ART
Placebo+ART
ISL+ART
Trial Design
2Treatment groups
Experimental Treatment
Group I: ISL+LENExperimental Treatment2 Interventions
Participants will receive the following for at least 48 weeks:
Day 1: LEN oral 600 mg (2 x 300 mg) and ISL 2 mg (2 x 1 mg)
Day 2: LEN only oral 600 mg (2 x 300 mg)
Day 8 and weekly thereafter (ie, every 7 days): LEN oral 300 mg (1 x 300 mg) and ISL 2 mg (2 x 1 mg)
Group II: B/F/TAFExperimental Treatment3 Interventions
Participants will receive the following for at least 48 weeks:
bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg once daily
After 48 weeks, participants will switch from B/F/TAF to ISL+LEN
Day 1: LEN oral 600 mg (2 x 300 mg) and ISL 2 mg (2 x 1 mg)
Day 2: LEN only oral 600 mg (2 x 300 mg)
Day 8 and weekly thereafter (ie, every 7 days): LEN oral 300 mg (1 x 300 mg) and ISL 2 mg
Participants who do not switch from B/F/TAF to ISL+LEN at Week 48 will be discontinued from the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ISL
2021
Completed Phase 3
~530
B/F/TAF
2016
Completed Phase 4
~4900
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,429 Total Patients Enrolled
Gilead SciencesLead Sponsor
1,082 Previous Clinical Trials
842,699 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
343 Previous Clinical Trials
186,693 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have previously used or been exposed to islatravir or lenacapavir.My kidney function is low, with a creatinine clearance of 30 mL/min or less.You must have an undetectable level of HIV-1 in your blood for at least 24 weeks prior to screening.My HIV-1 levels have been undetectable or very low for at least 24 weeks.I have been on B/F/TAF medication for at least 24 weeks.My HIV treatment failed to control the virus before.I have been on B/F/TAF medication for at least 24 weeks.I haven't had a serious infection needing IV treatment in the last 30 days.My HIV treatment has shown resistance to certain medications.I have tested positive for hepatitis B.I'm sorry, I cannot provide a summary for the term "key" as it is too vague and lacks context. Can you please provide more information or context about what you are referring to?You must have very low levels of HIV in your blood at the time of screening, less than 50 copies per milliliter.
Research Study Groups:
This trial has the following groups:- Group 1: ISL+LEN
- Group 2: B/F/TAF
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you provide a synopsis of the other experiments which have utilized ISL technology?
"Presently, there are 98 clinical trials investigating ISL. Of these studies, 22 have advanced to Phase 3 of the trial process. The majority of research is based in Boylston, MA but that accounts for just a fraction of the 1,609 sites running experiments with this drug."
Answered by AI
Does ISL pose any risk to patients when administered?
"There is some evidence of ISL's safety, so it obtained a rating of 2. However, there has yet to be any data collected on its efficacy."
Answered by AI
How many participants have been recruited for this clinical experiment?
"At this present moment, the clinical trial is not accepting participants. It was first listed on October 5th 2021 and updated lastly on July 12th 2022. However, for those still searching for a study to join, there are 106 trials with HIV-1 patients being recruited and 98 studies looking into ISL presently taking partipants."
Answered by AI
Are there still vacancies in this clinical trial open to participants?
"This clinical trial has already ceased participant recruitment, with its first posting on October 5th 2021 and last edit taking place July 12th 2022. For those looking for similar studies, there are 106 trials involving human immunodeficiency virus type 1 (hiv-1) infection that are actively recruiting as well as 98 ISL related projects seeking volunteers."
Answered by AI
Are there numerous locales currently conducting this experiment in the state?
"Peter Shalit, M.D., Floridian Clinical Research and Community Research Initiative of New England are amongst the 24 trial sites sponsoring this project in Seattle, Miami Lakes and Boston respectively."
Answered by AI
Who else is applying?
What state do they live in?
Nevada
California
What site did they apply to?
Huntridge Family Clinic
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
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