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Antiretroviral Therapy

Symtuza for HIV (ReSTART Trial)

Phase 4
Waitlist Available
Research Sponsored by The Crofoot Research Center, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 4, 12, 24, and 48
Awards & highlights

ReSTART Trial Summary

This trial will test if Symtuza, an HIV medication, is effective in patients who have been off of ART for 12 weeks or more.

Who is the study for?
This trial is for HIV-1 infected adults who have had previous antiretroviral treatment but stopped it at least 12 weeks ago. They must be able to swallow tablets and agree to use contraception. Excluded are those with certain infections, known drug resistance, severe liver or kidney disease, recent malignancy other than specific skin cancers, pregnancy or breastfeeding, substance abuse affecting adherence, or involvement in other studies.Check my eligibility
What is being tested?
The study tests the effectiveness of Symtuza®, a single tablet regimen containing Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (FDC), for rapidly restarting treatment in experienced patients off HIV therapy. It aims to assess how well this approach works when reintroducing ART.See study design
What are the potential side effects?
Potential side effects may include digestive issues like nausea and diarrhea; liver problems; rash; fatigue; headache; and changes in kidney function. Side effects vary by individual and should be monitored closely during the trial.

ReSTART Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 4, 12, 24, and 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 4, 12, 24, and 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The proportion of subjects who have HIV-1 RNA <50 copies/mL at week 48
Secondary outcome measures
Adherence as measured by pill count at Weeks 4, 12, 24, and 48
Change from baseline in HIV-1 RNA viral load
Change in baseline CD4 cell count
+15 more

ReSTART Trial Design

1Treatment groups
Experimental Treatment
Group I: Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (FDC)Experimental Treatment1 Intervention
Participants will receive oral tablet containing Darunavir 800 milligram (mg)/ Cobicistat 150 mg/ Emtricitabine 200 mg/ Tenofovir Alafenamide 10 mg (D/C/F/TAF) fixed-dose combination (FDC) once daily within 24 hours of the screening/baseline visit.

Find a Location

Who is running the clinical trial?

Janssen Scientific Affairs, LLCIndustry Sponsor
159 Previous Clinical Trials
580,443 Total Patients Enrolled
The Crofoot Research Center, Inc.Lead Sponsor
1 Previous Clinical Trials
200 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
New England Journal of MedicineJournal
Declining Morbidity and Mortality Among Patients with Advanced Human Immunodeficiency Virus Infection
Palella, Frank J., Jr., Kathleen M. Delaney, Anne C. Moorman, Mark O. Loveless, Jack Fuhrer, Glen A. Satten, Diane J. Aschman, and Scott D. Holmberg. 1998. “Declining Morbidity and Mortality Among Patients with Advanced Human Immunodeficiency Virus Infection”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejm199803263381301.
clinicaltrials.govStudy
Rapid Reinitiation of a Single Tablet Antiretroviral Therapy Using Symtuza® in HIV-1 Infected Treatment-Experienced Patients Off Therapy. (ReSTART)
2021. "Rapid Reinitiation of a Single Tablet Antiretroviral Therapy Using Symtuza® in HIV-1 Infected Treatment-Experienced Patients Off Therapy. (ReSTART)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04388904.
~21 spots leftby Apr 2025
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