Status:
COMPLETED
Nevirapine or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir in Human Immunodeficiency Virus (HIV)-1-infected Treatment Naive Adults
Lead Sponsor:
Boehringer Ingelheim
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Primary purpose of this study is to compare the efficacy and safety of two different nevirapine (Viramune) dosing regimens (once daily (QD) and twice daily (BID) application) and of atazanavir/ritonav...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Signed informed consent in accordance with Good Clinical Practice (GCP) and local regulatory requirements prior to trial participation
- HIV-1-infected males or females \>= 18 years of age with positive serology confirmed by Western blot
- No previous antiretroviral treatment (of more than 7 days)
- Males with CD4+ counts of \< 400 cells/mm3 and females with CD4+ counts of \< 250 cells/mm3
- NVP- and ATZ/r susceptibility based on HIV-1 genotypic resistance report
- Adequate renal function defined as a calculated creatinine clearance (CLCr) \>= 50 ml/min according to the Cockcroft-Gault formula
- Karnofsky score \>= 70
- Acceptable medical history, as assessed by the investigator
- Exclusion criteria:
Exclusion
- Active drug abuse or chronic alcoholism at the investigator's discretion
- Hepatic cirrhosis stage Child-Pugh B or C
- Female patients of child-bearing potential who:
- have a positive serum pregnancy test at screening or during the study,
- 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
- Laboratory parameters Division of Acquired Immunodeficiency Syndrome (DAIDS) \> grade 2 (triglycerides \> DAIDS grade 3; total cholesterol no restrictions)
- Active hepatitis B or C disease, defined as HBsAg-positive or Hepatitis C-Virus-Ribo Nucleic Acid (HCV-RNA)- positive with Aspartate Transaminase/Alanine Transaminase (AST/ALT) \> 2.5x Upper Limit of Normal (ULN) (DAIDS grade 1)
- Hypersensitivity to any ingredients of the test products
- Have therapy with nephrotoxic drugs (e.g., aminoglycosides, amphotericin B, vancomycin, cidofovir, foscarnet, cisplatin, pentamidine, tacrolimus, cyclosporine) or potential competitors of renal excretion (e.g., cidofovir, acyclovir, valacyclovir, ganciclovir, valganciclovir, probenecid, high-dose non-steroidal anti-inflammatory drugs (i.e., ibuprofen)) within 3 months prior to study screening or are expected to receive these during the study
- Patients who are receiving other concomitant treatments which are not permitted
- Use of other investigational medications 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, chronic treatment with prednisone)
- Patients 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
- Patients who are receiving systemic treatment for malignant disease
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
576 Patients enrolled
Trial Details
Trial ID
NCT00389207
Start Date
October 1 2006
Last Update
January 27 2014
Active Locations (68)
Enter a location and click search to find clinical trials sorted by distance.
1
1100.1470.54004 Boehringer Ingelheim Investigational Site
Capital Federal, Argentina
2
1100.1470.54002 Boehringer Ingelheim Investigational Site
Córdoba, Argentina
3
1100.1470.54003 Boehringer Ingelheim Investigational Site
Mar del Plata, Argentina
4
1100.1470.54001 Boehringer Ingelheim Investigational Site
Rosario, Argentina