Description:

ODM derived from http://clinicaltrials.gov/show/NCT00561925

Link:

http://clinicaltrials.gov/show/NCT00561925

Keywords:
Versions (3) ▾
  1. 12/10/13
  2. 4/15/14
  3. 9/20/21
Uploaded on:

September 20, 2021

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License:
Creative Commons BY 4.0
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Eligibility NCT00561925 HIV Infections

Details

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
age at least 18 Years
Signed informed consent in accordance with Good Clinical Practice and local regulatory requirements prior to trial participation
HIV-1 infected males or females >= 18 years of age with positive serology (ELISA) confirmed by Western blot
No previous antiretroviral treatment
Males with CD4+ counts >50 <400 cells/ml or females with CD4+ counts >50-<250 cells/ml
Adequate renal function defined as a calculated creatinine clearance (CLCr) >= 50 mL/min according to the Cockcroft-Gault formula as follows: Male: (140 age in years) x (weight in kg) divided by 72 x (serum creatinine in mg/dl) = CLCr (mL/min). Female: (140 age in years) x (weight in kg) divided by 72 x (serum creatinine in mg/dl) x 0.85 = CLCr (mL/min).
Karnofsky performance status (assessment scale)
An HIV-1 viral load of 1,000 copies/mL
Willingness to initiate CD4+ cell count-guided chemoprophylaxis to prevent important opportunistic infections as defined in Appendix 10.2
Willingness to abstain from ingesting substances which may alter plasma study drug levels by interaction with the cytochrome P450 system (listed in Appendix 10.3) during the study.
For centers participating in the PK substudy only: Written informed consent in accordance with GCP and local legislation for participation in the PK substudy. Refusal to participate in the PK substudy is not an exclusion criterion for participation in the trial. Only study centers with previous experience and equipped in handling PK samples are eligible for participation in the substudy.
Exclusion Criteria
Active drug abuse or chronic alcoholism at the investigator's discretion
Active hepatitis B or C disease, defined as HBsAg-positive and HBV-DNA-positive or HCV-RNA-positive
Female patients of child-bearing potential who: are pregnant at screening, are breast feeding, are planning to become pregnant are not willing to use a barrier method of contraception, or are not willing to use methods of contraception other than ethinyl estradiol containing oral contraceptives. Note: During participation in this study, females and males have to use barrier methods of contraception in addition or instead of ethinyl estradiol containing oral contraceptives.
Laboratory parameters >DAIDS Grade 2
ALT/AST > DAIDS Grade 1
Hypersensitivity to any ingredients of the test products
Previous use of Viramune (nevirapine) or any other antiretroviral agents (does not include use of single dose NVP for the prevention of mother to child transmission)
Resistance to NNRTIs or either one of the components of Truvada (emtricitabine or tenofovir disoproxil fumarate) or lamivudine (3TC) based on HIV-1 genotypic resistance testing report obtained at screening
Patients who are receiving other concomitant treatments which are not permitted, as described in the prescribing information
Use of investigational medications (any experimental agent other than the study regimen) within 30 days before study entry or during the trial
Use of immunomodulatory drugs within 30 days before study entry or during the trial (e.g., interferon, cyclosporin, hydroxyurea, interleukin 2)
Patients who have been diagnosed with malignant disease
Patients who in the opinion of the investigator are not candidates for inclusion in the study
Patient with Progressive Multifocal Leukoencephalopathy (PML), Visceral Kaposi's Sarcoma (KS), and/or any lymphoma
Any AIDS defining illness that is unresolved, symptomatic or not stable on treatment for at least 12 weeks at screening visit
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