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DOR/ISL for HIV

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Pacific Oaks Medical Group ( Site 5681), Beverly Hills, CAHIVDOR/ISL - Drug
Eligibility
18+
All Sexes
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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.

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

1
Antiretroviral treatment
1
Substudy-01: GS-5894
1
B/F/TAF (TOS)

Study Objectives

4 Primary · 10 Secondary · Reporting Duration: Baseline (Day 1) and Week 96

Week 48
Change from baseline in body weight at Week 48
Change from baseline in cluster of differentiation 4+ (CD4+) T-cells at Week 48
Week 96
Change from baseline in CD4+ T-cells at Week 96
Change from baseline in body weight at Week 96
Up to 48 weeks
Percentage of participants discontinuing from study treatment due to an AE through Week 48
Percentage of participants experiencing ≥1 adverse event (AE) through Week 48
Up to 96 weeks
Incidence of viral drug resistance
Percentage of participants discontinuing from study treatment due to an AE through Week 96
Percentage of participants experiencing ≥1 AE through Week 96
Week 48
Percentage of participants with HIV-1 RNA <200 copies/mL at Week 48
Percentage of participants with human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) <50 copies/mL at Week 48
Percentage of participants with human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) ≥50 copies/mL at Week 48
Week 96
Percentage of participants with HIV-1 RNA <200 copies/mL at Week 96
Percentage of participants with HIV-1 RNA <50 copies/mL at Week 96

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Antiretroviral treatment
1
Substudy-01: GS-5894
2
B/F/TAF (TOS)

Trial Design

2 Treatment Groups

BIC/FTC/TAF
1 of 2
DOR/ISL
1 of 2

Active Control

Experimental Treatment

500 Total Participants · 2 Treatment Groups

Primary Treatment: DOR/ISL · Has Placebo Group · Phase 3

DOR/ISLExperimental Group · 2 Interventions: DOR/ISL, Placebo to BIC/FTC/TAF · Intervention Types: Drug, Drug
BIC/FTC/TAFActiveComparator Group · 2 Interventions: BIC/FTC/TAF, Placebo to DOR/ISL · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DOR/ISL
2020
Completed Phase 2
~50

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline (day 1) and week 96

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,709 Previous Clinical Trials
4,966,858 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,655 Previous Clinical Trials
7,956,906 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

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References

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

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

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