Rapid Reinitiation of a Single Tablet Antiretroviral Therapy Using Symtuza® in HIV-1 Infected Tre… (NCT04388904) | Clinical Trial Compass
CompletedPhase 4
Rapid Reinitiation of a Single Tablet Antiretroviral Therapy Using Symtuza® in HIV-1 Infected Treatment-Experienced Patients Off Therapy. (ReSTART)
United States75 participantsStarted 2021-09-01
Plain-language summary
The purpose of this study is to demonstrate the effectiveness of Symtuza® in a rapid reinitiation model of care in patients with HIV-1 infection and who are treatment-experienced but have been off of antiretroviral therapy (ART) for 12 or more weeks.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* At least 18 years of age at screening/baseline visit.
* Antiretroviral treatment-experienced and have not received any anti-HIV treatment within 12 weeks prior to screening.
* Contraceptive use by men or women should be consistent with the local regulations regarding the use of contraceptive methods for subject participating in clinical studies.
* Men must agree not to donate sperm during the study until 90 days after receiving the last dose of study drug (or longer, if dictated by local regulations).
* Must be able to swallow whole tablets or swallow tablets cut into halves.
Exclusion Criteria:
* Known active cryptococcal infection, active toxoplasmic encephalitis, Mycobacterium tuberculosis infection, or another AIDS-defining condition that in the judgment of the investigator would increase the risk of morbidity or mortality.
* Known resistance to any of the components of D/C/F/TAF; subjects with known or identified FTC resistance attributed to an M184V mutation alone will be permitted to remain in the study.
* Prior virologic failure on a DRV-containing regimen from known history or from medical records.
* Known history of clinically relevant hepatic disease or hepatitis that in the investigator's judgment is not compatible with D/C/F/TAF.
* Known history of severe hepatic impairment as diagnosed based on documented history of severe hepatic impairment (Child-Pugh C).
* Known history of chronic (≥3 months) renal insufficiency, defined as having an …
What they're measuring
1
The proportion of subjects who have HIV-1 RNA <50 copies/mL at week 48