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Implication for Strategies of Long Term Control of Viral Replication in Patient With Primary HIV Infection (PHI).

NCT04225325 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2020-01-13

No results posted yet for this study

Summary

Multicenter, parallel group, randomised, open label, study. Twenty-five clinical centers constituting the InAction network will participate the study.

Eligible patients will be randomised in a ratio 10:10:8 to be treated with one of the three antiretroviral regimens:

* TDF/FTC 245 mg/200 mg single tablet QD + DRV /cobicistat 800 mg /150 mg single tablet QD (Arm A, standard regimen),
* TDF/FTC 245 mg/200 mg single tablet QD + DTG 50 mg QD (Arm B, standard regimen).
* TDF/FTC 245 mg/200 mg single tablet QD + DRV 800 mg /cobicistat single tablet QD + DTG 50 mg QD (Arm C, experimental regimen).

One-hundred-and-twelve PHI subjects will be recruited for this study among those attending the outpatient Clinic of Infectious Diseases, Ospedale San Raffaele and other Italian centres, involved in the INACTION network.

Conditions

Interventions

COMBINATION_PRODUCT

SYMTUZA

DESCOVY+REZOLSTA

COMBINATION_PRODUCT

DESCOVY+DOLUTEGRAVIR

DESCOVY+DOLUTEGRAVIR

COMBINATION_PRODUCT

SYMTUZA+DOLUTEGRAVIR

DESCOVY+REZOLSTA+DTG

Sponsors & Collaborators

  • Ministero della Salute, Italy

    collaborator OTHER

  • ADRIANO LAZZARIN, MD

    lead OTHER

Principal Investigators

  • GIUSEPPE TAMBUSSI · Ospedale San Raffaele

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-07
Primary Completion
2019-09-30
Completion
2021-06-14

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04225325 on ClinicalTrials.gov