← Back to Search

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

Approved for 10 Other Conditions

No Placebo-Only Group

All Individual Drugs Already Approved

Drug Has Already Been Approved

Pivotal 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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 4, 12, 24, and 48

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The proportion of subjects who have HIV-1 RNA <50 copies/mL at week 48

Secondary study objectives

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

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Darunavir

FDA approved

Do I qualify?Apply below to find out