PROTEA: A clinical trial comparing the efficacy of darunavir/ritonavir 800/100 mg monotherapy versus a triple combination therapy containing darunavir/ritonavir 800/100 mg and 2 nucleoside/nucleotide reverse transcriptase inhibitors in patients with undetectable plasma HIV-1 RNA on current treatment

• Register: EUCTR
• Last refreshed on: 16 November 2015
• Main ID: EUCTR2011-001635-23-IT
• Date of registration: 17/11/2011
• Prospective Registration: Yes
• Primary sponsor: JANSSEN-CILAG INTERNATIONAL N.V.
• Public title: PROTEA: A clinical trial comparing the efficacy of darunavir/ritonavir 800/100 mg monotherapy versus a triple combination therapy containing darunavir/ritonavir 800/100 mg and 2 nucleoside/nucleotide reverse transcriptase inhibitors in patients with undetectable plasma HIV-1 RNA on current treatment
• Scientific title: PROTEAse inhibitor (DRV/rtv) in mono- or triple therapy in suppressed HIV-1 infected subjects - PROTEA
• Date of first enrolment: 01/03/2012
• Target sample size: 260
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-001635-23
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: monotherapy vs triple combination therapy Number of treatment arms in the trial: 2

Countries of recruitment

Austria, Denmark, Germany, Hungary, Ireland, Israel, Italy, Poland, Spain, Sweden, Switzerland, United Kingdom

Contacts

• Name: Clinical Registry Group
• Affiliation: Janssen Biologics

• Name: Clinical Registry Group
• Affiliation: Janssen Biologics

Key inclusion & exclusion criteria

Inclusion criteria:
HIV-1 infection; receiving HAART for at least 48 weeks; Have plasma HIV-1 RNA <50 copies/mL for at least 48 weeks prior to screening; Be taking the same antiretroviral (ARV) combination for at least 8 weeks before screening; Have the preference, together with the physician, to change the current HAART regimen for reasons of simplification and/or toxicity.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 255
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion criteria:
Has a history of virologic failure defined as 2 consecutive plasma HIV-1 RNA >500 copies/mL while on previous or current antiretroviral therapy; Has a history of any primary PI mutations; Has clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels (liver insufficiency); Is diagnosed with acute viral hepatitis at screening or before Baseline 1; Is coinfected with hepatitis B


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Virus Diseases [C02]

HIV-1 infection
MedDRA version: 14.0 Level: LLT Classification code 10020192 Term: HIV-1 System Organ Class: 10021881 - Infections and infestations

Intervention(s)

Trade Name: Prezista
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: DARUNAVIR
CAS Number: 206361-99-1
Current Sponsor code: Darunavir ethanolate (formerly known as TMC114 ethanolate)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-

Trade Name: Norvir®
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: RITONAVIR
CAS Number: 155213-67-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Secondary Objective: 1. the correlation of plasma HIV-1 RNA, cerebrospinal fluid (CSF) HIV-1 RNA, and neurocognitive function of DRV/rtv monotherapy versus triple therapy containing DRV/rtv at week 48 2. change in neurocognitive function of DRV/rtv monotherapy versus triple therapy containing DRV/rtv over 48 and 96 weeks 3. the rate of plasma HIV-1 RNA suppression after 48 and 96 weeks of follow-up to DRV/rtv monotherapy versus triple therapy containing DRV/rtv, using the time to loss of virologic response (TLOVR) method. 4. the correlation of plasma HIV-1 RNA and neurocognitive function of DRV/rtv monotherapy versus triple therapy containing DRV/rtv at Weeks 48 and 96 5. the loss of treatment options as defined by treatment-emergent phenotypic drug resistance 6. the viral genotype of subjects 7. To evaluate and compare safety and tolerability

Main Objective: The primary objective is to demonstrate non-inferiority in terms of the percentage of subjects who have plasma HIV-1 RNA levels <50 copies/mL after 48 weeks of follow-up after switching to DRV/rtv monotherapy versus triple therapy containing DRV/rtv (FDA Snapshot method).

Primary end point(s): the percentage of patients who have (HIV-1) ribonucleic acid (RNA) levels <50 copies/mL after 48 weeks of follow-up after switching to DRV/ritonavir (rtv) monotherapy versus triple therapy containing DRV/rtv

Timepoint(s) of evaluation of this end point: 48 weeks

Secondary Outcome(s)

Secondary end point(s): -the correlation of plasma HIV-1 RNA, cerebrospinal fluid (CSF) HIV-1 RNA, and neurocognitive function of DRV/rtv monotherapy versus triple therapy containing DRV/rtv at week 48;-change in neurocognitive function of DRV/rtv monotherapy versus triple therapy containing DRV/rtv over 48 and 96 weeks;- the rate of plasma HIV-1 RNA suppression after 48 and 96 weeks of follow-up to DRV/rtv monotherapy versus triple therapy containing DRV/rtv, using the time to loss of virologic response (TLOVR) method;-the correlation of plasma HIV-1 RNA and neurocognitive function of DRV/rtv monotherapy versus triple therapy containing DRV/rtv at Weeks 48 and 96;-the loss of treatment options of DRV/rtv monotherapy versus triple therapy containing DRV/rtv at Weeks 48 and 96, as defined by treatment-emergent phenotypic drug resistance;- the viral genotype of subjects treated with DRV/rtv monotherapy versus triple therapy containing DRV/rtv over 48 and 96 weeks;-to evaluate and compare safety and tolerability of DRV/rtv monotherapy versus triple therapy containing DRV/rtv over 48 and 96 weeks.

Timepoint(s) of evaluation of this end point: 48 weeks and 96 weeks

Secondary ID(s)

2011-001635-23-GB

TMC114IFD3003

Source(s) of Monetary Support

Janssen Medical Affairs