Nevirapine or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir in Human Immunodeficiency Virus (HIV)-1-infected Treatment Naive Adults

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00389207
• Date of registration: 17/10/2006
• Primary sponsor: Boehringer Ingelheim Pharmaceuticals
• Public title: Nevirapine or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir in Human Immunodeficiency Virus (HIV)-1-infected Treatment Naive Adults
• Scientific title: Randomized, Open Label Study Evaluating the Lipid Profile Difference and Efficacy of a Combined Therapy Including Tenofovir, Emtricitabine + Atazanavir / r or NVP in Naive HIV - 1 Infected Patients.
• Date of first enrolment: October 2006
• Target sample size: 576
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00389207
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Argentina, Germany, Italy, Mexico, Poland, Portugal, Romania, Spain, Switzerland, United Kingdom, United States

Contacts

• Name: Boehringer Ingelheim
• Affiliation: Boehringer Ingelheim Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion criteria:

Inclusion Criteria:

1. Signed informed consent in accordance with Good Clinical Practice (GCP) and local
regulatory requirements prior to trial participation

2. HIV-1-infected males or females >= 18 years of age with positive serology confirmed
by Western blot

3. No previous antiretroviral treatment (of more than 7 days)

4. Males with CD4+ counts of < 400 cells/mm3 and females with CD4+ counts of < 250
cells/mm3

5. NVP- and ATZ/r susceptibility based on HIV-1 genotypic resistance report

6. Adequate renal function defined as a calculated creatinine clearance (CLCr) >= 50
ml/min according to the Cockcroft-Gault formula

7. Karnofsky score >= 70

8. Acceptable medical history, as assessed by the investigator

Exclusion criteria:

Exclusion Criteria:

1. Active drug abuse or chronic alcoholism at the investigator's discretion

2. Hepatic cirrhosis stage Child-Pugh B or C

3. 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

4. Laboratory parameters Division of Acquired Immunodeficiency Syndrome (DAIDS) > grade
2 (triglycerides > DAIDS grade 3; total cholesterol no restrictions)

5. 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)

6. Hypersensitivity to any ingredients of the test products

7. 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

8. Patients who are receiving other concomitant treatments which are not permitted

9. Use of other investigational medications within 30 days before study entry or during
the trial

10. 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)

11. Patients with Progressive Multifocal Leukoencephalopathy (PML), Visceral Kaposi's
Sarcoma (KS), and/or any lymphoma

12. Any AIDS defining illness that is unresolved, symptomatic or not stable on treatment
for at least 12 weeks at screening visit

13. Patients who are receiving systemic treatment for malignant disease



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infections

Intervention(s)

Drug: atazanavir

Drug: nevirapine bid

Drug: nevirapine qd

Primary Outcome(s)

Treatment Response at Week 48 [Time Frame: From baseline to Week 48]

Secondary Outcome(s)

Change in CD4+ Count From Baseline [Time Frame: From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT]

Change in Framingham Score From Baseline [Time Frame: From baseline to Weeks 48, 96 and 144/EOT]

Change in Mental Health Summary (MHS) Score From Baseline [Time Frame: From baseline to Weeks 48, 96 and 144/EOT]

Change in Physical Health Summary (PHS) Score From Baseline [Time Frame: From baseline to Weeks 48, 96 and 144/EOT]

Genotypic Resistance Associated With Virologic Failure [Time Frame: From baseline to Week 48]

Glycaemic Abnormalities [Time Frame: From baseline to Week 144]

Lipodystrophy [Time Frame: From baseline to Week 144]

Non-scheduled Physician Visits [Time Frame: From baseline to Week 24, Week 24 to 48, Week 48 to 96, and Week 96 to 144/EOT]

Number of Patients Hospitalized [Time Frame: From baseline to Week 24, Week 24 to 48, Week 48 to 96, and Week 96 to 144/EOT]

Proportion of Patients With VL < 400 Copies/ml [Time Frame: From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT]

Proportion of Patients With VL < 50 Copies/ml [Time Frame: From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT]

Serum Lipid Abnormalities [Time Frame: From baseline to Week 144]

Treatment Response at Week 48 (TLOVR Algorithm) [Time Frame: From baseline to Week 48]

Treatment-emergent AIDS-defining Illness [Time Frame: From baseline to Week 144]

Treatment-emergent AIDS-defining Illness Leading to Death [Time Frame: From baseline to Week 144]

Secondary ID(s)

1100.1470

2005-004330-40

Source(s) of Monetary Support

Please refer to primary and secondary sponsors