A Clinical Trial Comparing the Efficacy of Darunavir/Ritonavir Monotherapy Versus a Triple Combination Therapy Containing Darunavir/Ritonavir and 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Patients With Undetectable Plasma HIV-1 RNA on Current Treatment (PROTEA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag International NV
ClinicalTrials.gov Identifier:
NCT01448707
First received: June 2, 2011
Last updated: October 30, 2015
Last verified: October 2015
Results First Received: October 30, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Human Immunodeficiency Virus (HIV) Infections
Acquired Immunodeficiency Syndrome (AIDS) Virus
Interventions: Drug: Darunavir
Drug: Ritonavir

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
325 participants screened, among them 282 were eligible for run-in phase and among them 274 enrolled to the study. 1 randomized participant was not treated (273 participants were randomized).

Reporting Groups
  Description
DRV/Rtv MONO Darunavir (DRV) and ritonavir (rtv): 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
DRV/Rtv + 2NRTIs Darunavir (DRV), ritonavir (rtv) and 2 N[t]RTIs: 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC).

Participant Flow:   Overall Study
    DRV/Rtv MONO     DRV/Rtv + 2NRTIs  
STARTED     137     136  
COMPLETED     119     118  
NOT COMPLETED     18     18  
Adverse Event                 3                 1  
Lost to Follow-up                 2                 6  
Withdrawal by Subject                 6                 7  
Unspecified                 7                 4  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline characteristics were analyzed for all participants who were treated.

Reporting Groups
  Description
DRV/Rtv MONO Darunavir (DRV) and ritonavir (rtv): 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
DRV/Rtv + 2NRTIs Darunavir (DRV), ritonavir (rtv) and 2 N[t]RTIs: 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC).
Total Total of all reporting groups

Baseline Measures
    DRV/Rtv MONO     DRV/Rtv + 2NRTIs     Total  
Number of Participants  
[units: participants]
  137     136     273  
Age  
[units: years]
Mean (Standard Deviation)
  44.6  (11.21)     43.1  (10.41)     43.9  (10.82)  
Gender  
[units: participants]
     
Female     26     21     47  
Male     111     115     226  
Region of Enrollment  
[units: participants]
     
AUSTRIA     5     5     10  
BELGIUM     7     8     15  
DENMARK     8     7     15  
FRANCE     16     12     28  
GERMANY     11     11     22  
HUNGARY     5     3     8  
IRELAND     3     5     8  
ISRAEL     5     5     10  
ITALY     22     24     46  
POLAND     7     6     13  
SPAIN     17     23     40  
SWEDEN     3     4     7  
SWITZERLAND     10     5     15  
UNITED KINGDOM     18     18     36  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Virologic Response (Food Drug and Administration [FDA] Snapshot, Switch = Failure)   [ Time Frame: Week 48 ]

2.  Secondary:   Virologic Response (Food Drug and Administration [FDA] Snapshot, Switch = Failure)   [ Time Frame: Week 96 ]

3.  Secondary:   Virologic Response (FDA Snapshot, Switch Included)   [ Time Frame: Week 48 and 96 ]

4.  Secondary:   Change From Baseline in Global Neurocognitive Performance z Score   [ Time Frame: Baseline, Week 48 and 96 ]

5.  Secondary:   Time to Loss of Virologic Response   [ Time Frame: Baseline up to Week 96 or early withdrawal ]

6.  Secondary:   Number of Participants Reporting Treatment-Emergent Phenotypic Drug Resistance   [ Time Frame: At Weeks 48 and 96 ]

7.  Secondary:   Number of Participants Reporting Resistance Mutations With Confirmed Virologic Failure Who Have HIV RNA >400 Copies/mL and Genotype Resistance Results   [ Time Frame: Over 48 and 96 Weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: EMEA Medical Affairs Program Lead
Organization: Janssen Research & Development, LLC
e-mail: ClinicalTrialDisclosure@its.jnj.com


No publications provided


Responsible Party: Janssen-Cilag International NV
ClinicalTrials.gov Identifier: NCT01448707     History of Changes
Other Study ID Numbers: CR018370
TMC114IFD3003 ( Other Identifier: Janssen )
2011-001635-23 ( EudraCT Number )
PROTEA ( Other Identifier: Janssen )
Study First Received: June 2, 2011
Results First Received: October 30, 2015
Last Updated: October 30, 2015
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment