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HIV Viremia and Persistence in Acutely HIV-Infected Patients Treated With Darunavir/Ritonavir and Etravirine

This study has been terminated.
(Study halted by sponsor due to slow enrollment.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00855413
First Posted: March 4, 2009
Last Update Posted: October 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Janssen Pharmaceuticals
Information provided by (Responsible Party):
Cynthia L Gay, MD, University of North Carolina, Chapel Hill
Results First Submitted: February 24, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Acute HIV Infection
HIV Infections
Interventions: Drug: Darunavir
Drug: Ritonavir
Drug: Etravirine

  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
Individuals diagnosed with acute HIV in clinical sites within 30 days of enrollment and at least 18 years of age were enrolled. Acute HIV defined as: i) negative EIA and positive NAT; ii) positive EIA and positive NAT with negative/indeterminate western blot (WB); or iii) positive EIA, positive WB and EIA negative documentation in prior 30 days.

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
Acute HIV Infection Treatment Group All participants were administered darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis and continued for 48 weeks. Participants were evaluated on study at weeks 2, 4, 8, 12, 16, 24 and 48.

Participant Flow:   Overall Study
    Acute HIV Infection Treatment Group
STARTED   15 
COMPLETED   15 
NOT COMPLETED   0 



  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.
No text entered.

Reporting Groups
  Description
Acute HIV Infection Treatment Group All participants were administered darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis and continued for 48 weeks. Participants were evaluated on study at weeks 2, 4, 8, 12, 16, 24 and 48.

Baseline Measures
   Acute HIV Infection Treatment Group 
Overall Participants Analyzed 
[Units: Participants]
 15 
Age [1] [2] 
[Units: Years]
Median (Full Range)
 
Age   23 
 (19 to 51) 
[1] Median age and range of all participants enrolled in study
[2] years
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
 
Female      2  13.3% 
Male      13  86.7% 
[1] Gender of participants enrolled onto the study
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      3  20.0% 
Not Hispanic or Latino      12  80.0% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      11  73.3% 
White      4  26.7% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment [1] 
[Units: Participants]
 
United States   15 
[1] Region of enrollment for all participants


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Virologic Response   [ Time Frame: 24 weeks ]

2.  Secondary:   Number of Participants With Virologic Response   [ Time Frame: 48 weeks from enrollment ]

3.  Secondary:   Median Change in CD4 Cell Count From Week 0 to Week 24.   [ Time Frame: week 0, week 24 ]

4.  Secondary:   Median Change in CD4 Cell Count From Week 0 to Week 48.   [ Time Frame: 48 weeks from enrollment ]

5.  Secondary:   HIV RNA Levels Immediately Prior to Initiating Study Treatment.   [ Time Frame: HIV RNA level at enrollment ]

6.  Secondary:   Median Time to HIV RNA Suppression to <200 Copies/mL   [ Time Frame: From enrollment to the date of HIV RNA suppression, assessed up to Week 48 ]

7.  Secondary:   HIV RNA Detection in Semen   [ Time Frame: From enrollment through 48 weeks ]

8.  Secondary:   Number of Participants Who Stopped Study Treatment Due to Adverse Event or Intolerance   [ Time Frame: Enrollment to Week 48 ]

9.  Secondary:   Adverse Events Possibly or Definitely Related to Study Treatment Through Week 48   [ Time Frame: Enrollment to week 48 ]

10.  Secondary:   Maximum Etravirine Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture   [ Time Frame: Week 4 and week 48 ]

11.  Secondary:   Minimum Etravirine Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture   [ Time Frame: Week 4 and week 48 ]

12.  Secondary:   Maximum Darunavir Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture   [ Time Frame: Week 4 and week 48 ]

13.  Secondary:   Minimum Darunavir Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture   [ Time Frame: Week 4 and week 48 ]

14.  Secondary:   Maximum Ritonavir Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture   [ Time Frame: Week 4 and Week 48 ]

15.  Secondary:   Minimum Ritonavir Exposure Range in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture   [ Time Frame: Week 4 and week 48 ]

16.  Secondary:   Maximum Etravirine Exposure in Semen Among Participants Who Consented to an Optional Collection of Semen   [ Time Frame: Weeks 0-4 and weeks 12, 48 ]

17.  Secondary:   Minimum Etravirine Exposure in Semen Among Participants Who Consented to an Optional Collection of Semen   [ Time Frame: Weeks 0-4 and weeks 12, 48 ]

18.  Secondary:   Maximum Darunavir Exposure in Semen Among Participants Who Consented to an Optional Collection of Semen   [ Time Frame: Weeks 0-4 and weeks 12, 48 ]

19.  Secondary:   Minimum Darunavir Exposure Range in Semen Among Participants Who Consented to an Optional Collection of Semen   [ Time Frame: Weeks 0-4 and weeks 12, 48 ]

20.  Secondary:   Maximum Ritonavir Exposure in Semen Among Participants Who Consented to an Optional Collection of Semen   [ Time Frame: Weeks 0-4 and Weeks 12, 48 ]

21.  Secondary:   Minimum Ritonavir Exposure in Semen Among Participants Who Consented to an Optional Collection of Semen   [ Time Frame: Weeks 0-4 and Weeks 12, 48 ]

22.  Secondary:   Maximum Etravirine Exposure in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure   [ Time Frame: between Week 4-12 and between Weeks 36-48 ]

23.  Secondary:   Minimum Etravirine Exposure Range in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure   [ Time Frame: between Week 4-12 and between Weeks 36-48 ]

24.  Secondary:   Maximum Darunavir Exposure Range in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure   [ Time Frame: between Week 4-12 and between Weeks 36-48 ]

25.  Secondary:   Minimum Darunavir Exposure Range in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure   [ Time Frame: between week 4-12 and between weeks 36-48 ]

26.  Secondary:   Maximum Ritonavir Exposure Range in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure   [ Time Frame: between week 4-12 and between Weeks 36-48 ]

27.  Secondary:   Minimum Ritonavir Exposure Range in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure   [ Time Frame: between week 4-12 and between weeks 36-48 ]

28.  Secondary:   Number of Participants With HIV RNA Measurement Above the Limits of Detection in Cerebrospinal Fluid   [ Time Frame: Week 4 and Week 48 ]

29.  Secondary:   Number of Participants With Neurocognitive Impairment at Baseline   [ Time Frame: Week 2 or 4 ]

30.  Secondary:   Number of Participants With Neurocognitive Impairment at Week 24   [ Time Frame: Week 24 ]

31.  Secondary:   Number of Participants With Neurocognitive Impairment at Week 48   [ Time Frame: Week 48 ]

32.  Secondary:   Overall Neurocognitive Impairment Score at Week 2 or 4   [ Time Frame: Week 2 or 4 ]

33.  Secondary:   Overall Neurocognitive Impairment at Week 24   [ Time Frame: Week 24 ]

34.  Secondary:   Overall Neurocognitive Impairment at Week 48   [ Time Frame: Week 48 ]

35.  Secondary:   Change in Overall Neurocognitive Impairment From Baseline to Week 24 or 48   [ Time Frame: Baseline to Week 24 or 48 ]

36.  Secondary:   Correlation of HIV RNA Levels in CSF and Drug Levels With Neurocognitive Functioning   [ Time Frame: From enrollment through Week 48 ]

37.  Secondary:   Correlation of Time to HIV RNA Levels <200 Copies/mL With Improvement in Neurocognitive Functioning From Baseline to Week 24 and 48   [ Time Frame: Baseline to Week 24 and 48 ]

38.  Secondary:   HIV RNA Detection in Ileal Biopsy Specimens   [ Time Frame: Weeks 4 and 48 ]


  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
Early termination prior to target enrollment due to slow enrollment limited analysis involving optional procedures. Lack of paired (baseline and followup) samples from optional procedures also limited ability to perform these analyses.


  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: Dr. Cynthia Gay
Organization: The University of North Carolina
phone: 9198432726
e-mail: cynthia_gay@med.unc.edu


Publications:
C Gay, A Johnson, S McCoy, J Kuruc, K McGee, L McNeil, M Kerkau, J Sebastian, C Pilcher, D Margolis, P Leone, S Fiscus, G Ferrari, C Hicks, J Eron, The Duke-UNC Acute HIV Infection Consortium. "Efficacy of NNRTI-based antiretroviral therapy initiated during acute HIV infection." XVII International AIDS Conference, 2008 Abstract no. THPE0082.
C Gay, O Dibben, A Stacey, N Gasper-Smith, M Liu, N Goonetilleke, G Ferrari, J Eron, C Hicks, A McMichael, B Haynes, P Borrow, M Cohen, the Duke-UNC CHAVI 001 Clinical Working Group. "Effect(s) of antiretroviral treatment on acute HIV infection." XVII International AIDS Conference, 2008 Abstract no. THPE0086.


Responsible Party: Cynthia L Gay, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00855413     History of Changes
Other Study ID Numbers: CID 0821
First Submitted: March 2, 2009
First Posted: March 4, 2009
Results First Submitted: February 24, 2017
Results First Posted: October 17, 2017
Last Update Posted: October 17, 2017