Trial Outcomes & Findings for A Two Year Study of the Clinical Efficacy of the Combination of Emtricitabine, Tenofovir, and Nevirapine (NCT NCT00344461)

NCT ID: NCT00344461

Last Updated: 2021-11-01

Results Overview

The primary outcome is sustained Virologic response, defined as HIV-1 RNA \<500 copies/mL until trial completion at 96 weeks.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 54 participants
• Primary outcome timeframe: 96 Weeks
• Results posted on: 2021-11-01

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	54
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	21

Reasons for withdrawal

Measure	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.
Overall Study Adverse Event	6
Overall Study Death	1
Overall Study Lack of Efficacy	2
Overall Study Lost to Follow-up	2
Overall Study Physician Decision	2
Overall Study Protocol Violation	6
Overall Study Withdrawal by Subject	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	TDF, FTC & NVP n=54 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	54 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	51 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	54 participants n=5 Participants

PRIMARY outcome

Timeframe: 96 Weeks

Population: 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

The primary outcome is sustained Virologic response, defined as HIV-1 RNA <500 copies/mL until trial completion at 96 weeks.

Outcome measures

Measure	Single Group (TDF/FTC & NVP) n=54 Participants 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.
Number of Participants With Sustained Virologic Response	33 Participants

SECONDARY outcome

Timeframe: Protocol length is 96 weeks

The number of participants with grades 2,3 and 4 adverse events and laboratory toxicities.

Outcome measures

Measure	Single Group (TDF/FTC & NVP) n=54 Participants 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.
Patients With Grade 2, 3 and 4 Adverse Events and Laboratory Toxicities	13 Participants

SECONDARY outcome

Timeframe: 96 weeks.

The number of participants with plasma HIV RNA < 50 copies/mL

Outcome measures

Measure	Single Group (TDF/FTC & NVP) n=54 Participants 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.
Patients With Plasma HIV RNA < 50 Copies/mL	32 Participants

SECONDARY outcome

Timeframe: 96 weeks

The number of participants with plasma HIV RNA < 400 copies/mL

Outcome measures

Measure	Single Group (TDF/FTC & NVP) n=54 Participants 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.
Patients With Plasma HIV RNA < 400 Copies/mL	32 Participants

SECONDARY outcome

Timeframe: Baseline to week 96

Percent Change From Baseline in Plasma HIV RNA at 96 weeks

Outcome measures

Measure	Single Group (TDF/FTC & NVP) n=54 Participants 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.
Change in Plasma HIV RNA From Baseline to Week 96	3.32 percentage of change Standard Deviation .043

SECONDARY outcome

Timeframe: Baseline to week 96

To determine the mean change from Baseline in CD4 cell count to week 96.

Outcome measures

Measure	Single Group (TDF/FTC & NVP) n=54 Participants 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.
Changes in CD4 Cell Count From Baseline and Week 96	252 percentage of CD4 Increase Standard Deviation 89.91

Adverse Events

FTC, TDF, & NVP

Serious events: 16 serious events

Other events: 13 other events

Deaths: 1 deaths

Serious adverse events

Measure	FTC, TDF, & NVP n=54 participants at risk 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.
Blood and lymphatic system disorders Neutrapenia	3.7% 2/54 • Number of events 2 • 96 weeks 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.
Blood and lymphatic system disorders Sepsis	1.9% 1/54 • Number of events 1 • 96 weeks 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.
Hepatobiliary disorders Grade 3 & 4 Liver Function Test	1.9% 1/54 • Number of events 1 • 96 weeks 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.
Respiratory, thoracic and mediastinal disorders Pneumonia	7.4% 4/54 • Number of events 4 • 96 weeks 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.
Hepatobiliary disorders Grade 4 alanine aminotransferase (ALT) test	1.9% 1/54 • Number of events 1 • 96 weeks 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.
Skin and subcutaneous tissue disorders Rash	1.9% 1/54 • Number of events 1 • 96 weeks 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.
Eye disorders CMV Retinitis	1.9% 1/54 • Number of events 1 • 96 weeks 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.
Blood and lymphatic system disorders Malignant Lymphoma	1.9% 1/54 • Number of events 1 • 96 weeks 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.
Vascular disorders Aortic Aneurysm	1.9% 1/54 • Number of events 1 • 96 weeks 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.
Respiratory, thoracic and mediastinal disorders Diffused Lung Disease	1.9% 1/54 • Number of events 1 • 96 weeks 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.
Vascular disorders Right Femoral Deep Vein Thrombosis	1.9% 1/54 • Number of events 1 • 96 weeks 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.
Hepatobiliary disorders Hepatotoxicity	1.9% 1/54 • Number of events 1 • 96 weeks 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.

Other adverse events

Measure	FTC, TDF, & NVP n=54 participants at risk 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.
General disorders Syncopy	3.7% 2/54 • Number of events 2 • 96 weeks 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.
Psychiatric disorders Depression	3.7% 2/54 • Number of events 2 • 96 weeks 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.
General disorders Sinusitis	1.9% 1/54 • Number of events 1 • 96 weeks 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.
General disorders Drug Detoxicity	1.9% 1/54 • Number of events 1 • 96 weeks 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.
Respiratory, thoracic and mediastinal disorders Bronchitis	1.9% 1/54 • Number of events 1 • 96 weeks 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.
Eye disorders Herpes Zoster Othalmicus	1.9% 1/54 • Number of events 1 • 96 weeks 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.
General disorders Left Hand Trauma	1.9% 1/54 • Number of events 1 • 96 weeks 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.
General disorders Stabbing	1.9% 1/54 • Number of events 1 • 96 weeks 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.
Gastrointestinal disorders Viral Gastroenteritis	1.9% 1/54 • Number of events 1 • 96 weeks 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.
Eye disorders Preseptal Cellulitis	1.9% 1/54 • Number of events 1 • 96 weeks 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.
Infections and infestations Viral Syndrome	1.9% 1/54 • Number of events 1 • 96 weeks 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.
Musculoskeletal and connective tissue disorders Abscess Right Leg	1.9% 1/54 • Number of events 1 • 96 weeks 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.

Additional Information

Charles E. Davis, Jr., MD

University of Maryland, Institute Of Human Virology

Phone: 410-706-4608

Email: cdavis@ihv.umaryland.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place