Evaluating Once Daily Etravirine in Treatment-Naive Adults With HIV Infection

This study has been completed.
Sponsor:
Collaborator:
Janssen Pharmaceuticals
Information provided by (Responsible Party):
Michelle Floris-Moore, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00959894
First received: August 14, 2009
Last updated: May 11, 2015
Last verified: May 2015
Results First Received: March 27, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Etravirine (Intelence)
Drug: Truvada

  Participant Flow
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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
80 participants were enrolled, however 1 participant was found to be ineligible on the day of entry and never started study medication (had developed acute renal failure and therefore no longer met eligibility requirements).

Reporting Groups
  Description
Etravirine 400 mg Once Daily

Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily

Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day


Participant Flow:   Overall Study
    Etravirine 400 mg Once Daily  
STARTED     79 [1]
COMPLETED     63  
NOT COMPLETED     16  
Lost to Follow-up                 10  
Adverse Event                 3  
Withdrawal by Subject                 1  
Need for contraindicated medication                 1  
Subject moved out of town                 1  
[1] One (1) additional subject became ineligible on the day of entry and never started study medication.



  Baseline Characteristics
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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.
All participants who received at least one dose of study medication (etravirine 400 mg given once daily with with one tablet of fixed dose tenofovir/emtricitabine).

Reporting Groups
  Description
Etravirine 400 mg Once Daily

Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily

Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day


Baseline Measures
    Etravirine 400 mg Once Daily  
Number of Participants  
[units: participants]
  79  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     79  
>=65 years     0  
Age  
[units: years]
Median (Inter-Quartile Range)
  29    (23 to 44)  
Gender  
[units: participants]
 
Female     8  
Male     71  
Region of Enrollment  
[units: participants]
 
United States     79  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Antiretroviral Activity of Etravirine 400 mg Given Once Daily, With Fixed-dose Truvada Once Daily, Among Treatment-naïve HIV-1 Infected Adults as Measured by the Percentage of Participants With HIV RNA < 50 Copies/mL at Week 24   [ Time Frame: 24 weeks ]

2.  Secondary:   The Proportion of Participants With HIV RNA <50 Copies/mL at Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine   [ Time Frame: 48 weeks ]

3.  Secondary:   The Proportion of Participants With HIV RNA <50 Copies/mL at Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine   [ Time Frame: 96 weeks ]

4.  Secondary:   The Proportion of Participants With HIV RNA <200 Copies/mL at Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine   [ Time Frame: 24 weeks ]

5.  Secondary:   The Proportion of Participants With HIV RNA <200 Copies/mL at Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine   [ Time Frame: 48 weeks ]

6.  Secondary:   The Proportion of Participants With HIV RNA <200 Copies/mL at Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine   [ Time Frame: 96 weeks ]

7.  Secondary:   Change in CD4+ Cell Count From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine   [ Time Frame: Baseline to 24 weeks ]

8.  Secondary:   Change in CD4+ Cell Count From Baseline to Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine   [ Time Frame: Baseline to 48 weeks ]

9.  Secondary:   Change in CD4+ Cell Count From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine   [ Time Frame: Baseline to 96 weeks ]

10.  Secondary:   Resistance Mutations in the Subset of Patients With Confirmed Virologic Failure Who Have HIV RNA >500 Copies/mL and Genotype Resistance Results   [ Time Frame: 96 weeks ]

11.  Secondary:   Tolerability of Etravirine in HIV-1 Infected Adults Initiating Antiretroviral Therapy   [ Time Frame: 96 weeks ]

12.  Secondary:   Probability of Remaining Free of a Safety/Tolerability Event at 96 Weeks   [ Time Frame: 96 weeks ]

13.  Secondary:   Change in the Lipid Profile and Glucose Metabolism, in a Subgroup of up to 40 Participants, From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine   [ Time Frame: Baseline to 24 weeks ]

14.  Secondary:   Change in Glucose Metabolism (Insulin Resistance), in a Subgroup of up to 40 Participants, From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine   [ Time Frame: Baseline to 24 weeks ]

15.  Secondary:   Change in the Lipid Profile and Glucose Metabolism, in a Subgroup of up to 40 Participants, From Baseline to Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine   [ Time Frame: Baseline to 48 weeks ]

16.  Secondary:   Change in Glucose Metabolism (Insulin Resistance), in a Subgroup of up to 40 Participants, From Baseline to Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine   [ Time Frame: Baseline to 48 weeks ]

17.  Secondary:   Change in the Lipid Profile and Glucose Metabolism, in a Subgroup of up to 40 Participants, From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine   [ Time Frame: Baseline to 96 weeks ]

18.  Secondary:   Change in Glucose Metabolism (Insulin Resistance), in a Subgroup of up to 40 Participants, From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine   [ Time Frame: Baseline to 96 weeks ]

19.  Secondary:   Change in Limb and Trunk Fat Distribution as Measured by DEXA Scan, in the Same Subgroup of up to 40 Participants (as in Aim 8), From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine   [ Time Frame: Baseline to 24 weeks ]

20.  Secondary:   Change in Limb and Trunk Fat Distribution as Measured by DEXA Scan, in the Same Subgroup of up to 40 Participants (as in Aim 8), From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine   [ Time Frame: Baseline to 96 weeks ]

21.  Secondary:   Change in Fat Mass Ratio as Measured by DEXA Scan, in the Same Subgroup of up to 40 Participants (as in Aim 8), From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine   [ Time Frame: Baseline to 24 weeks ]

22.  Secondary:   Change in Fat Mass Ratio as Measured by DEXA Scan, in the Same Subgroup of up to 40 Participants (as in Aim 8), From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine   [ Time Frame: Baseline to 96 weeks ]

23.  Secondary:   Pharmacokinetics of Etravirine in Genital Secretions of up to 10 Men and up to 10 Women at Week 4 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine   [ Time Frame: 4 weeks ]
Results not yet reported.   Anticipated Reporting Date:   09/2015   Safety Issue:   No

24.  Secondary:   Population Pharmacokinetics of Etravirine 400 mg Once Daily, in Combination With Fixed-dose Emtricitabine-tenofovir Among Treatment-naïve HIV-1 Infected Adults   [ Time Frame: At or after 4 weeks ]
Results not yet reported.   Anticipated Reporting Date:   09/2015   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
Pharmacokinetic (PK) data for two of the secondary outcomes of this study are pending. The lab in which these assays are conducted was relocated during the study and lab operations were therefore delayed. The PK assessment is currently in progress.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Michelle Floris-Moore, M.D., M.S.
Organization: UNC School of Medicine
phone: 919-966-2537
e-mail: mfloris@med.unc.edu


Publications:
Scholler-Gyure M, Kakuda TN, De Smedt G, Woodfall B, Lachaert R, Beets G, Peeters M, Hoetelmans RM. Pharmacokinetics of TMC125 in once- and twice- daily regimens in HIV-1-negative volunteers. Program and Abstracts of the 47th Interscience Conference on Antimicrobial Agents and Chemotherapy, 2007 [Abstract A-1427], Chicago IL.
Lalezari J, et al. Pharmacokinetics of once-daily etravirine (ETR) without and with once-daily darunavir/ritonavir (DRV/r) in antiretroviral-naïve HIV-1 infected adults. 9th International Congress on Drug Therapy in HIV Infection 2008; abstract O413.


Responsible Party: Michelle Floris-Moore, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00959894     History of Changes
Other Study ID Numbers: 08-2070
Study First Received: August 14, 2009
Results First Received: March 27, 2015
Last Updated: May 11, 2015
Health Authority: United States: Food and Drug Administration