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Implication for Strategies of Long Term Control of Viral Replication in Patient With Primary HIV Infection (PHI). (P25-INACTION)

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ClinicalTrials.gov Identifier: NCT04225325
Recruitment Status : Recruiting
First Posted : January 13, 2020
Last Update Posted : January 13, 2020
Sponsor:
Collaborator:
Ministero della Salute, Italy
Information provided by (Responsible Party):
ADRIANO LAZZARIN, MD, Ospedale San Raffaele

Brief 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.


Condition or disease Intervention/treatment Phase
HIV-1-infection Combination Product: SYMTUZA Combination Product: DESCOVY+DOLUTEGRAVIR Combination Product: SYMTUZA+DOLUTEGRAVIR Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Implication for Strategies of Long Term Control of Viral Replication in Patient With Primary HIV Infection (PHI) Treated With Multitarget Antiviral Therapy (MT-ART)
Actual Study Start Date : May 7, 2018
Actual Primary Completion Date : September 30, 2019
Estimated Study Completion Date : June 14, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: A: SYMTUZA
TAF/FTC 245 mg/200 mg single tablet QD +DRV /cobicistat 800 mg /150 mg single tablet QD
Combination Product: SYMTUZA
DESCOVY+REZOLSTA

Active Comparator: B: DESCOVY+DOLUTEGRAVIR
TAF/FTC 245 mg/200 mg single tablet QD+DTG 50 mg QD
Combination Product: DESCOVY+DOLUTEGRAVIR
DESCOVY+DOLUTEGRAVIR

Experimental: C: SYMTUZA+DOLUTEGRAVIR
TAF/FTC 245 mg/200 mg single tablet QD+DRV/cobicistat single tablet QD + +DTG 50 mg QD
Combination Product: SYMTUZA+DOLUTEGRAVIR
DESCOVY+REZOLSTA+DTG




Primary Outcome Measures :
  1. the change of total HIV-DNA level from baseline to 48 weeks. [ Time Frame: 48 weeks ]
    The primary objective of the study is to compare the proviral DNA change in patients who started three different antiretroviral treatments.


Secondary Outcome Measures :
  1. the proportion of patients with HIV-1 RNA <50 copies/mL [ Time Frame: weeks 12, 24 and 48 ]
    proportion of patients with HIV-1 RNA <50 copies/mL at week 24 and week 48;

  2. time to achieve undetectable viral load [ Time Frame: week 12 and week 48 ]
    HIV-1 RNA <50 copies/mL

  3. change in HIV-DNA [ Time Frame: week 12 and week 48 ]
    the change of total copies/mL OF HIV-DNA level from baseline to 48 weeks

  4. change in HIV-1 RNA in CSF [ Time Frame: week 12 and 48 ]
    the change of total copies/mL of HIV-RNA level in cerebrospinal fluid



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

  • Subjects must be at least 18 years of age at the time of randomization, of either sex and of any race.
  • Primary HIV Infection defined according to Fiebig's classification.
  • Subjects must have given written informed consent and must be able to adhere to dose and visit schedules.
  • Female subjects of child-bearing potential must agree to use a medically accepted method of contraception.
  • Female subjects of child-bearing potential must have a negative serum beta-hCG pregnancy test at Screening, and a negative urine beta-HCG pregnancy test on Day 1 prior to dosing.
  • A female, may be eligible to enter and participate in the study if she:

    1. is of non-child-bearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy;
    2. is of child-bearing potential with a negative pregnancy test at both Screening and Day 1 and agrees to use one of the following methods of contraception to avoid pregnancy:
  • Complete abstinence from penile-vaginal intercourse from 2 weeks prior to administration of IP, throughout the study, and for at least 2 weeks after discontinuation of all study medications;
  • Double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide);
  • Any intrauterine device (IUD) with published data showing that the expected failure rate is <1% per year (not all IUDs meet this criterion, see Appendix 4 for an example listing of approved IUDs);
  • Male partner sterilization confirmed prior to the female subject's entry into the study, and this male is the sole partner for that subject;
  • Approved hormonal contraception for subjects randomized to arm B (TDF/FTC + DTG)
  • Approved hormonal contraception and a barrier method for subjects randomized to arm A (TDF/FTC +DRV/cobicistat) and C (TDF/FTC +DRV/cobicistat +DTG)
  • Any other method with published data showing that the expected failure rate is <1% per year.
  • Any contraception method must be used consistently, in accordance with the approved product label and for at least 2 weeks after discontinuation of IP. -Approved hormonal contraception for subjects randomized to the treatment groups should be specified.

EXCLUSION CRITERIA:

  • Female subjects of childbearing potential who are breastfeeding, pregnant, or planning to become pregnant.
  • Subjects with active opportunistic infection or malignancy.
  • Subjects positive for Hepatitis B at screening (+HBsAg), or anticipated need for Hepatitis C virus (HCV) therapy during the study.
  • Subjects with known liver cirrhosis.
  • Subjects with any clinically significant condition or situation other than the condition being studied that, in the opinion of investigator, would interfere with the study evaluations or optimal participation.
  • Subjects with allergy/sensitivity to drugs or its excipients.
  • History or presence of allergy to the study drugs or their components
  • Alanine aminotransferase (ALT) 5 times the upper limit of normal (ULN), OR ALT 3xULN and bilirubin 1.5xULN (with >35% direct bilirubin)
  • Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
  • Subjects with severe hepatic impairment (Class C) as determined by Child-Pugh classification
  • Subject has creatinine clearance of <70 mL/min via Cockroft-Gault method
  • Hepatic failure (Child-Plug grade C)
  • Use of not modifiable concomitant drugs: carbamazepine, fenitoine, fenobarbital, rifampicine, Hypericum perforatum, dofelitide.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04225325


Contacts
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Contact: SILVIA NOZZA 0226437961 ext +39 nozza.silvia@hsr.it

Locations
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Italy
Ospedale San Raffaele Recruiting
Milan, MI, Italy, 20127
Contact: SILVIA NOZZA    +39.0226437961    nozza.silvia@hsr.it   
Contact: MARIA RITA PARISI    +39.0226433646    parisi.mariarita@hsr.it   
Sponsors and Collaborators
ADRIANO LAZZARIN, MD
Ministero della Salute, Italy
Investigators
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Study Chair: GIUSEPPE TAMBUSSI Ospedale San Raffaele

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Responsible Party: ADRIANO LAZZARIN, MD, HEAD OF INFECTIOUS DISEASES CLINIC, Ospedale San Raffaele
ClinicalTrials.gov Identifier: NCT04225325    
Other Study ID Numbers: P25-INACTION
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by ADRIANO LAZZARIN, MD, Ospedale San Raffaele:
antiretroviral drugs
HIV viral reservoir
HIV acute infection
Additional relevant MeSH terms:
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Infection
Communicable Diseases
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Dolutegravir
Emtricitabine
Darunavir
Cobicistat
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
HIV Protease Inhibitors
Protease Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors