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DRIVESHAFT: Darunavir/Ritonavir In HIV-infected Virologically-suppressed Experienced Subjects (DRIVESHAFT)

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ClinicalTrials.gov Identifier: NCT01423812
Recruitment Status : Completed
First Posted : August 26, 2011
Results First Posted : February 7, 2018
Last Update Posted : February 7, 2018
Sponsor:
Collaborator:
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
Information provided by (Responsible Party):
Gregory Huhn, Ruth M. Rothstein CORE Center

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: HIV
Interventions: Drug: Twice-daily Darunavir and ritonavir
Drug: Once-daily Darunavir and ritonavir

  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
No text entered.

Reporting Groups
  Description
Once-daily Darunavir/Ritonavir

Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily to Darunavir 800mg plus Ritonavir 100mg once-daily

Once-daily Darunavir/ritonavir: Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily at baseline to Darunavir 800mg plus Ritonavir 100mg once-daily for 48 weeks

Twice-daily Darunavir/Ritonavir

Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily

Twice-daily Darunavir/ritonavir: Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily


Participant Flow:   Overall Study
    Once-daily Darunavir/Ritonavir   Twice-daily Darunavir/Ritonavir
STARTED   30   30 
COMPLETED   27   26 
NOT COMPLETED   3   4 
Lost to Follow-up                2                2 
Withdrawal by Subject                1                2 



  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.
No text entered.

Reporting Groups
  Description
Once-daily Darunavir/Ritonavir

Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily to Darunavir 800mg plus Ritonavir 100mg once-daily

Once-daily Darunavir/ritonavir: Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily at baseline to Darunavir 800mg plus Ritonavir 100mg once-daily for 48 weeks

Twice-daily Darunavir/Ritonavir

Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily

Twice-daily Darunavir/ritonavir: Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily

Total Total of all reporting groups

Baseline Measures
   Once-daily Darunavir/Ritonavir   Twice-daily Darunavir/Ritonavir   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   30   60 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      30 100.0%      29  96.7%      59  98.3% 
>=65 years      0   0.0%      1   3.3%      1   1.7% 
Age 
[Units: Years]
Mean (Full Range)
 48 
 (36 to 65) 
 49 
 (38 to 66) 
 48 
 (36 to 66) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      6  20.0%      5  16.7%      11  18.3% 
Male      24  80.0%      25  83.3%      49  81.7% 
Region of Enrollment 
[Units: Participants]
     
United States   30   30   60 


  Outcome Measures

1.  Primary:   Primary Efficacy Endpoint for Virologic Suppression in HIV-infected Subjects   [ Time Frame: 48 weeks after randomization to study medication ]

2.  Secondary:   Secondary Efficacy Endpoints   [ Time Frame: week 24 ]

3.  Secondary:   Secondary Efficacy Endpoints   [ Time Frame: Within 48 weeks after randomization to study medication ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Safety Assessment   [ Time Frame: Within 48 weeks of randomization to study medications ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Immunologic Endpoints   [ Time Frame: 48 weeks after randomization to study medications ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Assessment of Virologic Failure   [ Time Frame: Within 48 weeks of randomization to study medications ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Secondary:   Medication Adherence Assessment   [ Time Frame: Within 48 weeks of randomization to study medications ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  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
The sample size was not adequately powered to evaluate non-inferiority, which might be clinically relevant. As a single-center study, identifying an appropriate number of eligible patients to determine non-inferiority was not feasible.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Gregory Huhn, MD
Organization: The Ruth M. Rothstein CORE Center
phone: 312-572-4575
e-mail: ghuhn@cookcountyhhs.org


Publications:
1. De Meyer S, et al. Antiviral activity of TMC 114, a potent next generation protease inhibitor against more than 4000 recent recombinant clinical isolates exhibiting a wide range of protease inhibitor resistance profile. Antiviral Ther 2003;8:3S19. 2. De Meyer S, et al. In vitro selection experiments demonstrate an increased genetic barrier to resistance development to TMC 114 as compared with currently licensed protease inhibitors. Antiviral Ther 2002;7(Suppl 1):S5. 3. De Meyer SD, et al. Phenotypic and genotypic determinants of resistance to TMC 114: pooled analysis of POWER 1,2, and 3. Antiviral Ther 2006;11:S83. 4. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. December 1,2009;1-161. Available at http://www.aidsinfo.nih.gov/ContentFiles/Adultand AdolescentGL.pdf. Accessed September 15, 2010. 5. Clotet B, et al. Efficacy and Safety of Darunavir/ritonavir at week 48 in treatment-experienced patients with HIV-1 infection in POWER 1 and 2: A Pooled Subgroup Analysis of Data from Two Randomized Trials. The Lancet 2007;369:1169-78. 6. Cahn PK, et al. Efficacy and Safety at 48 Weeks of Once-daily vs Twice-daily DRV.r in Treatment-experienced HIV-1-positive Patients with No DRV Resistance-associated Mutations: The ODIN Trial. Abstract 57. 17th Conference on Retroviruses and Opportunistic Infections (CROI 2010). San Francisco. February 16-19, 2010. 7. Moltó J, et al. Treatment simplification to once daily darunavir/ritonavir guided by the darunavir inhibitory quotient in heavily pretreated HIV-infected patients. Antivir Ther. 2010;15(2):219-25. 8. Paterson DL, et al. Adherence to protease inhibitor therapy and outcomes in patients with HIV infection. Ann Intern Med 2000;133:21-30.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Gregory Huhn, Ruth M. Rothstein CORE Center
ClinicalTrials.gov Identifier: NCT01423812     History of Changes
Other Study ID Numbers: TMC114HIV4063
First Submitted: August 24, 2011
First Posted: August 26, 2011
Results First Submitted: September 15, 2015
Results First Posted: February 7, 2018
Last Update Posted: February 7, 2018