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

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

Brief Summary:
Open label, two year study of the clinical efficacy of the combination of FTC, Tenofovir, and Nevirapine. Sixty HIV infected patients without previous exposure to antiretroviral therapy will be enrolled. Study will include a pharmacokinetic substudy to evaluate the interaction of FTC and Nevirapine. Truvada may be used.

Condition or disease Intervention/treatment Phase
HIV Drug: Nevirapine, FTC, and Tenofovir Phase 4

Detailed Description:

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 This cutoff for women is based on unpublished data that there may be increased hepatotoxicity in women with a CD4 cell count 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cell Cycle Independent Antiretroviral Therapy: Combination of Nevirapine, FTC, and Tenofovir
Study Start Date : March 2004
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. Patients With Plasma HIV RNA < 50 Copies/mL [ Time Frame: 96 weeks. ]
    The number of participants with plasma HIV RNA < 50 copies/mL

  3. Patients With Plasma HIV RNA < 400 Copies/mL [ Time Frame: 96 weeks ]
    The number of participants with plasma HIV RNA < 400 copies/mL

  4. 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

  5. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. HIV-1 infection, as documented by any licensed ELISA test kit, and confirmed by Western blot, positive HIV-1 blood culture, positive HIV serum antigen, or plasma viremia at any time prior to study entry. If no record exists, testing must occur at screening.
  2. Male or female, age 18 to 75 years of age.
  3. Able to sign the informed consent, and is willing to comply with the requirements of this clinical trial.
  4. Available for at least 96 weeks of follow up.
  5. Males: deemed a candidate for antiretroviral therapy per referring primary care provider. (If patient is self referred, CD4 cell count must be <400 cells/mm3 and viral load>5,000c/ml) Females: CD4 cell count must be less than 250 cells/mm3 and viral load >5,000 c/mL at time of enrollment.
  6. If female and of child bearing potential must consent to using at least two forms of contraception.
  7. Participants will be "treatment naive" as no prior antiretroviral therapy or antiretroviral therapy for less than 7 days in the past.

Exclusion Criteria:

  1. Evidence of mutation associated with primary drug resistance to Nevirapine (K103N, Y181C, Y188L, G190S), Tenofovir (M41L, T69 insertion, Q151M, L210W,and K65R), and/or FTC (184V) previously documented, or at time of screening.
  2. Patients with any of the following laboratory parameters at the screening visit: estimated creatinine clearance of <60 ml/min; aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 times the upper limits of normal; total bilirubin >1.5 mg/dL.
  3. Women with CD4 cell count > 250 cells/ mm3 at time of entry or in males with a CD4 cell count less than 400/mm3, along with a viral load greater than 5,000c/ml. for both males and females.
  4. Pregnant women or women who are breast feeding.
  5. Unwillingness to use effective barrier contraception.
  6. Patients with current alcohol abuse or illicit drug use that in the opinion of the Principal Investigator may interfere with the patient's ability to comply with the protocol requirements.
  7. Patients with malabsorption or severe chronic diarrhea for more than 30 days.
  8. Current treatment for malignancy other than basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
  9. History of any chronic illness or other condition that in the opinion of the investigator would interfere with the conduct or completion of the study.
  10. Patient who is, in the opinion of the investigator, unable to complete the 96-week dosing period and protocol evaluations and assessments.
  11. Experimental vaccines, to include HIV vaccines.
  12. Patient who is currently enrolled in an experimental protocol, or is receiving an experimental medication.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00344461

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United States, Maryland
University of Maryland, Institute of Human Virology
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland, College Park
Boehringer Ingelheim
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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
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Charles E. Davis, Jr., Principal Investigator, University of Maryland, College Park Identifier: NCT00344461    
Other Study ID Numbers: H-23783
First Posted: June 26, 2006    Key Record Dates
Results First Posted: November 14, 2017
Last Update Posted: November 14, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers