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

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ClinicalTrials.gov Identifier: NCT00344461
Recruitment Status : Completed
First Posted : June 26, 2006
Results First Posted : November 14, 2017
Last Update Posted : November 14, 2017
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Charles E. Davis, Jr., University of Maryland

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
Enrollment 54
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Single Group (TDF/FTC & NVP)
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 54
Completed 33
Not Completed 21
Reason Not Completed
Adverse Event             6
Death             1
Lack of Efficacy             2
Lost to Follow-up             2
Physician Decision             2
Protocol Violation             6
Withdrawal by Subject             2
Arm/Group Title TDF, FTC & NVP
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
<=18 years
0
   0.0%
Between 18 and 65 years
54
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
Female
19
  35.2%
Male
35
  64.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 54 participants
54
1.Primary Outcome
Title Number of Participants With Sustained Virologic Response
Hide Description The primary outcome is sustained Virologic response, defined as HIV-1 RNA <500 copies/mL until trial completion at 96 weeks.
Time Frame 96 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
HIV-1 infected Males: cluster of differentiation 4 (CD4) cell count less than 400 cells/mm3 and viral load greater than 5,000c/ml) Females: CD4 cell count less than 250 cells/mm3 and viral load greater than 5,000 c/mL at time of enrollment. Treatment naive
Arm/Group Title Single Group (TDF/FTC & NVP)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 54
Measure Type: Count of Participants
Unit of Measure: Participants
33
2.Secondary Outcome
Title Patients With Grade 2, 3 and 4 Adverse Events and Laboratory Toxicities
Hide Description The number of participants with grades 2,3 and 4 adverse events and laboratory toxicities.
Time Frame Protocol length is 96 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nevirapine, FTC, Tenofovir
Hide Arm/Group Description:

Open Label Drugs- Nevirapine 200 mg twice a day, FTC 200 mg once a day and Tenofovir 300 mg once a day for 96 weeks.

Nevirapine, FTC, and Tenofovir: One arm only - Open label using FTC 200 mg p.o. qd, and Tenofovir 300 mg p.o. qd, and Nevirapine 200 mg b.i.d.

Overall Number of Participants Analyzed 54
Measure Type: Count of Participants
Unit of Measure: Participants
13
3.Secondary Outcome
Title Patients With Plasma HIV RNA < 50 Copies/mL
Hide Description The number of participants with plasma HIV RNA < 50 copies/mL
Time Frame 96 weeks.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Group (TDF/FTC & NVP)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 54
Measure Type: Count of Participants
Unit of Measure: Participants
32
  59.3%
4.Secondary Outcome
Title Patients With Plasma HIV RNA < 400 Copies/mL
Hide Description The number of participants with plasma HIV RNA < 400 copies/mL
Time Frame 96 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nevirapine, FTC, Tenofovir
Hide Arm/Group Description:

Open Label Drugs- Nevirapine 200 mg twice a day, FTC 200 mg once a day and Tenofovir 300 mg once a day for 96 weeks.

Nevirapine, FTC, and Tenofovir: One arm only - Open label using FTC 200 mg p.o. qd, and Tenofovir 300 mg p.o. qd, and Nevirapine 200 mg b.i.d.

Overall Number of Participants Analyzed 54
Measure Type: Count of Participants
Unit of Measure: Participants
32
  59.3%
5.Secondary Outcome
Title Change in Plasma HIV RNA From Baseline to Week 96
Hide Description Percent Change From Baseline in Plasma HIV RNA at 96 weeks
Time Frame Baseline to week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nevirapine, FTC, Tenofovir
Hide Arm/Group Description:

Open Label Drugs- Nevirapine 200 mg twice a day, FTC 200 mg once a day and Tenofovir 300 mg once a day for 96 weeks.

Nevirapine, FTC, and Tenofovir: One arm only - Open label using FTC 200 mg p.o. qd, and Tenofovir 300 mg p.o. qd, and Nevirapine 200 mg b.i.d.

Overall Number of Participants Analyzed 54
Mean (Standard Deviation)
Unit of Measure: percentage of change
3.32  (.043)
6.Secondary Outcome
Title Changes in CD4 Cell Count From Baseline and Week 96
Hide Description To determine the mean change from Baseline in CD4 cell count to week 96.
Time Frame Baseline to week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nevirapine, FTC, Tenofovir
Hide Arm/Group Description:

Open Label Drugs- Nevirapine 200 mg twice a day, FTC 200 mg once a day and Tenofovir 300 mg once a day for 96 weeks.

Nevirapine, FTC, and Tenofovir: One arm only - Open label using FTC 200 mg p.o. qd, and Tenofovir 300 mg p.o. qd, and Nevirapine 200 mg b.i.d.

Overall Number of Participants Analyzed 54
Mean (Standard Deviation)
Unit of Measure: percentage of CD4 Increase
252  (89.91)
Time Frame 96 weeks
Adverse Event Reporting Description A written report will be filed with the Institutional Review Board (IRB) within 5 working days for serious adverse event and annually for all others.
 
Arm/Group Title FTC, TDF, & NVP
Hide Arm/Group Description 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.
All-Cause Mortality
FTC, TDF, & NVP
Affected / at Risk (%)
Total   1/54 (1.85%)    
Show Serious Adverse Events Hide Serious Adverse Events
FTC, TDF, & NVP
Affected / at Risk (%) # Events
Total   16/54 (29.63%)    
Blood and lymphatic system disorders   
Neutrapenia *  2/54 (3.70%)  2
Sepsis *  1/54 (1.85%)  1
Malignant Lymphoma *  1/54 (1.85%)  1
Eye disorders   
CMV Retinitis *  1/54 (1.85%)  1
Hepatobiliary disorders   
Grade 3 & 4 Liver Function Test *  1/54 (1.85%)  1
Grade 4 alanine aminotransferase (ALT) test *  1/54 (1.85%)  1
Hepatotoxicity *  1/54 (1.85%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumonia *  4/54 (7.41%)  4
Diffused Lung Disease *  1/54 (1.85%)  1
Skin and subcutaneous tissue disorders   
Rash * [1]  1/54 (1.85%)  1
Vascular disorders   
Aortic Aneurysm *  1/54 (1.85%)  1
Right Femoral Deep Vein Thrombosis *  1/54 (1.85%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Stevens Johnson
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
FTC, TDF, & NVP
Affected / at Risk (%) # Events
Total   13/54 (24.07%)    
Eye disorders   
Herpes Zoster Othalmicus *  1/54 (1.85%)  1
Preseptal Cellulitis *  1/54 (1.85%)  1
Gastrointestinal disorders   
Viral Gastroenteritis *  1/54 (1.85%)  1
General disorders   
Syncopy *  2/54 (3.70%)  2
Sinusitis *  1/54 (1.85%)  1
Drug Detoxicity *  1/54 (1.85%)  1
Left Hand Trauma *  1/54 (1.85%)  1
Stabbing *  1/54 (1.85%)  1
Infections and infestations   
Viral Syndrome *  1/54 (1.85%)  1
Musculoskeletal and connective tissue disorders   
Abscess Right Leg *  1/54 (1.85%)  1
Psychiatric disorders   
Depression *  2/54 (3.70%)  2
Respiratory, thoracic and mediastinal disorders   
Bronchitis *  1/54 (1.85%)  1
*
Indicates events were collected by non-systematic assessment
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
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