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A Two Year Study of the Clinical Efficacy of the Combination of Emtricitabine, Tenofovir, and Nevirapine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00344461
First Posted: June 26, 2006
Last Update Posted: November 14, 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:
Boehringer Ingelheim
Information provided by (Responsible Party):
Charles E. Davis, Jr., University of Maryland
Results First Submitted: October 2, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: HIV
Intervention: Drug: Nevirapine, FTC, and Tenofovir

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Single Group (TDF/FTC & NVP) To evaluate the long-term antiviral activity of a three cell cycle independent reverse transcriptase regimen consisting of Nevirapine 200mg twice-a-day, Tenofovir 300mg and Emtricitabine 200mg once-a-day in the treatment of patients with chronic HIV infection.

Participant Flow:   Overall Study
    Single Group (TDF/FTC & NVP)
STARTED   54 
COMPLETED   33 
NOT COMPLETED   21 
Adverse Event                6 
Death                1 
Lack of Efficacy                2 
Lost to Follow-up                2 
Physician Decision                2 
Protocol Violation                6 
Withdrawal by Subject                2 



  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.
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Reporting Groups
  Description
TDF, FTC & NVP To evaluate the long-term antiviral activity of a three cell cycle independent reverse transcriptase regimen consisting of Nevirapine 200mg twice-a-day, Tenofovir 300mg and Emtricitabine 200mg once-a-day in the treatment of patients with chronic HIV infection.

Baseline Measures
   TDF, FTC & NVP 
Overall Participants Analyzed 
[Units: Participants]
 54 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      54 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      19  35.2% 
Male      35  64.8% 
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      51  94.4% 
White      2   3.7% 
More than one race      0   0.0% 
Unknown or Not Reported      1   1.9% 
Region of Enrollment 
[Units: Participants]
 
United States   54 


  Outcome Measures
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1.  Primary:   Number of Participants With Sustained Virologic Response   [ Time Frame: 96 Weeks ]

2.  Secondary:   Patients With Grade 2, 3 and 4 Adverse Events and Laboratory Toxicities   [ Time Frame: Protocol length is 96 weeks ]

3.  Secondary:   Patients With Plasma HIV RNA < 50 Copies/mL   [ Time Frame: 96 weeks. ]

4.  Secondary:   Patients With Plasma HIV RNA < 400 Copies/mL   [ Time Frame: 96 weeks ]

5.  Secondary:   Change in Plasma HIV RNA From Baseline to Week 96   [ Time Frame: Baseline to week 96 ]

6.  Secondary:   Changes in CD4 Cell Count From Baseline and Week 96   [ Time Frame: Baseline to week 96 ]


  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
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  More Information
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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: Charles E. Davis, Jr., MD
Organization: University of Maryland, Institute Of Human Virology
phone: 410-706-4608
e-mail: cdavis@ihv.umaryland.edu


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

Responsible Party: Charles E. Davis, Jr., University of Maryland
ClinicalTrials.gov Identifier: NCT00344461     History of Changes
Other Study ID Numbers: H-23783
First Submitted: June 22, 2006
First Posted: June 26, 2006
Results First Submitted: October 2, 2015
Results First Posted: November 14, 2017
Last Update Posted: November 14, 2017