A Two Year Study of the Clinical Efficacy of the Combination of Emtricitabine, Tenofovir, and Nevirapine
|ClinicalTrials.gov Identifier: NCT00344461|
Recruitment Status : Completed
First Posted : June 26, 2006
Results First Posted : November 14, 2017
Last Update Posted : November 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|HIV||Drug: Nevirapine, FTC, and Tenofovir||Phase 4|
Description of study design This is an open-labeled clinical trial evaluating an antiretroviral treatment regimen in which the drugs have demonstrated in vitro activity in both, resting and activated mononuclear cells. These drugs include: FTC 200 mg p.o. qd, and Tenofovir 300 mg p.o. qd, and Nevirapine 200 mg b.i.d.
Eligible patients must be at least 18 years of age, be referred by their primary HIV provider for antiretroviral therapy or if the patient is self referred, have a cluster of differentiation 4 (CD4) cell count of < 250/mm3 and have a viral load >5,000c/ml. Eligibility requirement for women is that they must have a CD4 cell count of <250 at the time of enrollment. This cutoff for women is based on unpublished data that there may be increased hepatotoxicity in women with a CD4 cell count > 250 cell/mm3. The screening evaluation will take place the day the informed consent is signed. During that screening evaluation, the patient will undergo a history and physical examination, and will have study labs drawn. Within 60 days of the screening evaluation and meeting all eligible criteria, the patient will be placed on the study treatment regimen. Patients will be evaluated at the clinic on Day 0 (therapy initiation), weeks 2, 4, 6, 8, 12, 16, and then every 8 weeks until 48 weeks and thereafter every 12 weeks through week 96. At the end of the study, all patients may continue their current antiretroviral treatment regimen at the discretion of the patient and their primary care provider.
Pharmacokinetic Analysis Sub Study A pharmacokinetic evaluation will be performed in first 7 volunteers to assess the impact of FTC on Nevirapine and vice versa. Pharmacokinetic analysis will be performed at end of week 2 ( day 14) during 200mg qd start up period. Samples will be obtained at baseline and 1, 3, 6, 12 and 24 hours post Nevirapine dosing. Pharmacokinetic analysis will be repeated at the week 8 visit. Samples will be obtained at baseline and 1, 3, 6, 12 and 24 hours post Nevirapine.
Assignment of patients There will be 60 patients involved in this clinical trial. This is an open-labeled study. There are no placebos involved in this study.
Dose and dose selection The dosages of medications are those that are currently used as standard clinical practice: Nevirapine 200 mg b.i.d. (1-200 mg tablet b.i.d.); Emtricitabine (FTC) 200mg po qd.(1-200mg capsule); Tenofovir 300 mg once-a-day (1-300 mg tablet qd).
Justification of study design All study patients require treatment for their HIV infection. All of the drugs used in this study are FDA-Approved. Tenofovir and FTC are approved as a once-a-day treatment medication. Nevirapine (NVP) is approved for BID dosing.
NOTE: That whenever Nevirapine is being prescribed, there will be a lead-in period of 14 days in which Nevirapine will be prescribed as 200 mg once a day followed by 200 mg BID as is the recommended standard of care.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cell Cycle Independent Antiretroviral Therapy: Combination of Nevirapine, FTC, and Tenofovir|
|Study Start Date :||March 2004|
|Primary Completion Date :||July 2008|
|Study Completion Date :||July 2008|
Experimental: Nevirapine, FTC, Tenofovir
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.
Drug: 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.
- Number of Participants With Sustained Virologic Response [ Time Frame: 96 Weeks ]The primary outcome is sustained Virologic response, defined as HIV-1 RNA <500 copies/mL until trial completion at 96 weeks.
- Patients With Grade 2, 3 and 4 Adverse Events and Laboratory Toxicities [ Time Frame: Protocol length is 96 weeks ]The number of participants with grades 2,3 and 4 adverse events and laboratory toxicities.
- Patients With Plasma HIV RNA < 50 Copies/mL [ Time Frame: 96 weeks. ]The number of participants with plasma HIV RNA < 50 copies/mL
- Patients With Plasma HIV RNA < 400 Copies/mL [ Time Frame: 96 weeks ]The number of participants with plasma HIV RNA < 400 copies/mL
- Change in Plasma HIV RNA From Baseline to Week 96 [ Time Frame: Baseline to week 96 ]Percent Change From Baseline in Plasma HIV RNA at 96 weeks
- Changes in CD4 Cell Count From Baseline and Week 96 [ Time Frame: Baseline to week 96 ]To determine the mean change from Baseline in CD4 cell count to week 96.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00344461
|United States, Maryland|
|University of Maryland, Institute of Human Virology|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator:||Robert R Redfield, MD||University of Maryland, School of Medicine, IHV|
|Principal Investigator:||Charles E Davis, MD||University of Maryland, School of Medicine, IHV|