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DOR/ISL for HIV
Study Summary
This trial tests the safety, effectiveness and tolerance of a new HIV-1 treatment for people who haven't had any treatment before.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I was diagnosed with a serious infection related to AIDS within the last month.I haven't had cancer in the last 5 years, except for certain skin cancers or in situ cervical cancer.I am infected with HIV-2.I have an active hepatitis B infection.I have chronic hepatitis C with signs of cirrhosis.I am not pregnant, breastfeeding, and willing to use birth control or abstain from sex if I can have children.I have never taken HIV medication since my diagnosis.
- Group 1: DOR/ISL
- Group 2: BIC/FTC/TAF
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Are participants still being accepted for this research?
"As indicated on clinicaltrials.gov, new participants are being welcomed into this medical trial that was first announced on March 8th 2023 and further revised 14 days later."
What potential risks might patients encounter with DOR/ISL treatments?
"Our evaluation by Power granted DOR/ISL a score of 3 due to the prior clinical data validating its safety, as this is an advanced Phase 3 trial."
What are the major goals of this clinical experiment?
"Per Merck Sharp & Dohme LLC, the primary outcome which will be tracked over 48 weeks is the Percentage of participants with human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) ≥50 copies/mL at Week 48. Secondary outcomes being evaluated include Percentage of participants experiencing any Adverse Events in a 96 week timeframe, Percentage of those discontinuing from study treatment due to an AE through Week 96 and finally the Percentage of individuals with HIV-1 RNA <50 copies/mL at Week 96 using PCR assays that detect lower than 50 copies/ml."
What is the current participant pool for this research endeavor?
"Indeed, data hosted on clinicaltrials.gov affirms that this medical study is presently recruiting patients. First posted on March 8th 2023, the trial requires 500 participants from a single site for completion."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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