VERxVE Study on Efficacy and Safety of Nevirapine XR in Comparison to Nevirapine IR With Truvada in Naive HIV+ Patients

NCT00561925 | Completed Phase 3 Results

• 2 other identifiers: 1100.14862007-003654-29
• Study Type: interventional
• Target: 1,068
• Locations: 21 countries
• Sites: 202

Brief Summary

The primary objective of this study is to evaluate the efficacy of 400 mg QD nevirapine extended release (NVP XR) formulation versus 200 mg BID nevirapine immediate release (NVP IR) in ARV therapy naïve HIV-1 infected patients after 48 weeks of treatment. Secondary objectives are to evaluate safety and pharmacokinetics of NVP XR and NVP IR.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• Comparison of Proportion of Virologic Response at Week 48 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population

  Primary endpoint was the number of patients with a sustained virologic response through week 48 using LLOQ = 50 copies/mL

  week 48

Secondary Outcomes (14)

• Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population

  week 0 to 144

• Proportion of Sustained Virologic Response at Week 144 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population

  week 144

• Kaplan-Meier Estimates for Time to New AIDS or AIDS-related Progression Event or Death, Full Analysis Set Population

  week 0 to 144

• Comparison of HIV-1 Viral Load (log10 Copies/mL) Change From Baseline at Week 144, Full Analysis Set Population

  baseline, week 144

• Comparison of CD4+ Cell Count (Cells/Cubic Millimeter) Change From Baseline at Week 144, Full Analysis Set Population

  baseline, week 144

Study Arms (2)

nevirapine XR

EXPERIMENTAL

400 mg QD

Drug: nevirapine XR

nevirapine IR

ACTIVE COMPARATOR

200 mg BID

Drug: nevirapine IR

Interventions

nevirapine IR DRUG

200 mg BID

nevirapine IR

nevirapine XR DRUG

400 mg QD

nevirapine XR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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) greater than or equal to 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 score \>70 (see Appendix 10.4)
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (202)

1100.1486.0040 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Location

1100.1486.0013 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

Location

1100.1486.0017 Boehringer Ingelheim Investigational Site

Bakersfield, California, United States

Location

1100.1486.0001 Boehringer Ingelheim Investigational Site

Beverly Hills, California, United States

Location

1100.1486.0057 Boehringer Ingelheim Investigational Site

Beverly Hills, California, United States

Location

1100.1486.0059 Boehringer Ingelheim Investigational Site

Beverly Hills, California, United States

Location

1100.1486.0035 Boehringer Ingelheim Investigational Site

Long Beach, California, United States

Location

1100.1486.0025 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

1100.1486.0034 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

1100.1486.0041 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

1100.1486.0032 Boehringer Ingelheim Investigational Site

Sacramento, California, United States

Location

1100.1486.0028 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Location

1100.1486.0023 Boehringer Ingelheim Investigational Site

Washington D.C., District of Columbia, United States

Location

1100.1486.0029 Boehringer Ingelheim Investigational Site

Washington D.C., District of Columbia, United States

Location

1100.1486.0048 Boehringer Ingelheim Investigational Site

Washington D.C., District of Columbia, United States

Location

1100.1486.0037 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

Location

1100.1486.0043 Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, United States

Location

1100.1486.0012 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Location

1100.1486.0007 Boehringer Ingelheim Investigational Site

Miami Beach, Florida, United States

Location

1100.1486.0039 Boehringer Ingelheim Investigational Site

Orlando, Florida, United States

Location

1100.1486.0050 Boehringer Ingelheim Investigational Site

Vero Beach, Florida, United States

Location

1100.1486.0014 Boehringer Ingelheim Investigational Site

Wilton Manors, Florida, United States

Location

1100.1486.0031 Boehringer Ingelheim Investigational Site

Atlanta, Georgia, United States

Location

1100.1486.0010 Boehringer Ingelheim Investigational Site

Macon, Georgia, United States

Location

1100.1486.0053 Boehringer Ingelheim Investigational Site

Boise, Idaho, United States

Location

1100.1486.0002 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Location

1100.1486.0026 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Location

1100.1486.0020 Boehringer Ingelheim Investigational Site

Lexington, Kentucky, United States

Location

1100.1486.0019 Boehringer Ingelheim Investigational Site

Berkley, Michigan, United States

Location

1100.1486.0006 Boehringer Ingelheim Investigational Site

Kansas City, Missouri, United States

Location

1100.1486.0027 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Location

1100.1486.0055 Boehringer Ingelheim Investigational Site

Charlotte, North Carolina, United States

Location

1100.1486.0003 Boehringer Ingelheim Investigational Site

Huntersville, North Carolina, United States

Location

1100.1486.0005 Boehringer Ingelheim Investigational Site

Akron, Ohio, United States

Location

1100.1486.0004 Boehringer Ingelheim Investigational Site

Austin, Texas, United States

Location

1100.1486.0018 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Location

1100.1486.0038 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Location

1100.1486.0044 Boehringer Ingelheim Investigational Site

Fort Worth, Texas, United States

Location

1100.1486.0054 Boehringer Ingelheim Investigational Site

Harlingen, Texas, United States

Location

1100.1486.0009 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

1100.1486.0046 Boehringer Ingelheim Investigational Site

Annandale, Virginia, United States

Location

1100.1486.5401 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

Location

1100.1486.5402 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

Location

1100.1486.5404 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

Location

1100.1486.5407 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

Location

1100.1486.5408 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

Location

1100.1486.5403 Boehringer Ingelheim Investigational Site

Mar del Plata, Argentina

Location

1100.1486.5409 Boehringer Ingelheim Investigational Site

Quilmes, Argentina

Location

1100.1486.5405 Boehringer Ingelheim Investigational Site

Rosario, Argentina

Location

1100.1486.6101 Boehringer Ingelheim Investigational Site

Darlinghurst, New South Wales, Australia

Location

1100.1486.6102 Boehringer Ingelheim Investigational Site

Darlinghurst, New South Wales, Australia

Location

1100.1486.6104 Boehringer Ingelheim Investigational Site

Surry Hills, New South Wales, Australia

Location

1100.1486.6103 Boehringer Ingelheim Investigational Site

Brisbane, Queensland, Australia

Location

1100.1486.3208 Boehringer Ingelheim Investigational Site

Bruges, Belgium

Location

1100.1486.3201 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

1100.1486.3203 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

1100.1486.3205 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

1100.1486.3207 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

1100.1486.3209 Boehringer Ingelheim Investigational Site

Charleroi, Belgium

Location

1100.1486.3202 Boehringer Ingelheim Investigational Site

Ghent, Belgium

Location

1100.1486.3204 Boehringer Ingelheim Investigational Site

Liège, Belgium

Location

1100.1486.3206 Boehringer Ingelheim Investigational Site

Liège, Belgium

Location

1100.1486.2605 Boehringer Ingelheim Investigational Site

Francistown, Botswana

Location

1100.1486.2601 Boehringer Ingelheim Investigational Site

Gaborone, Botswana

Location

1100.1486.2603 Boehringer Ingelheim Investigational Site

Gaborone, Botswana

Location

1100.1486.1002 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Location

1100.1486.1004 Boehringer Ingelheim Investigational Site

Winnipeg, Manitoba, Canada

Location

1100.1486.1013 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Location

1100.1486.1016 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Location

1100.1486.1005 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

1100.1486.1010 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

1100.1486.1014 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

1100.1486.1011 Boehringer Ingelheim Investigational Site

Quebec (Ste Foy), Quebec, Canada

Location

1100.1486.3305A Boehringer Ingelheim Investigational Site

Angers, France

Location

1100.1486.3305B Boehringer Ingelheim Investigational Site

Angers, France

Location

1100.1486.3307A Boehringer Ingelheim Investigational Site

Bondy, France

Location

1100.1486.3317A Boehringer Ingelheim Investigational Site

Bordeaux, France

Location

1100.1486.3316A Boehringer Ingelheim Investigational Site

Brest, France

Location

1100.1486.3316B Boehringer Ingelheim Investigational Site

Brest, France

Location

1100.1486.3314E Boehringer Ingelheim Investigational Site

Caen, France

Location

1100.1486.3304A Boehringer Ingelheim Investigational Site

Clamart, France

Location

1100.1486.3308A Boehringer Ingelheim Investigational Site

Lyon, France

Location

1100.1486.3308C Boehringer Ingelheim Investigational Site

Lyon, France

Location

1100.1486.3301A Boehringer Ingelheim Investigational Site

Nantes, France

Location

1100.1486.3301B Boehringer Ingelheim Investigational Site

Nantes, France

Location

1100.1486.3301C Boehringer Ingelheim Investigational Site

Nantes, France

Location

1100.1486.3301D Boehringer Ingelheim Investigational Site

Nantes, France

Location

1100.1486.3301E Boehringer Ingelheim Investigational Site

Nantes, France

Location

1100.1486.3301F Boehringer Ingelheim Investigational Site

Nantes, France

Location

1100.1486.3301G Boehringer Ingelheim Investigational Site

Nantes, France

Location

1100.1486.3301H Boehringer Ingelheim Investigational Site

Nantes, France

Location

1100.1486.3301I Boehringer Ingelheim Investigational Site

Nantes, France

Location

1100.1486.3306A Boehringer Ingelheim Investigational Site

Nice, France

Location

1100.1486.3303A Boehringer Ingelheim Investigational Site

Paris, France

Location

1100.1486.3303B Boehringer Ingelheim Investigational Site

Paris, France

Location

1100.1486.3303C Boehringer Ingelheim Investigational Site

Paris, France

Location

1100.1486.3303D Boehringer Ingelheim Investigational Site

Paris, France

Location

1100.1486.3312A Boehringer Ingelheim Investigational Site

Paris, France

Location

1100.1486.3312B Boehringer Ingelheim Investigational Site

Paris, France

Location

1100.1486.3309A Boehringer Ingelheim Investigational Site

Saint-Etienne, France

Location

1100.1486.3309B Boehringer Ingelheim Investigational Site

Saint-Etienne, France

Location

1100.1486.3318A Boehringer Ingelheim Investigational Site

Toulon, France

Location

1100.1486.3318B Boehringer Ingelheim Investigational Site

Toulon, France

Location

1100.1486.3318C Boehringer Ingelheim Investigational Site

Toulon, France

Location

1100.1486.3318D Boehringer Ingelheim Investigational Site

Toulon, France

Location

1100.1486.3302A Boehringer Ingelheim Investigational Site

Toulouse, France

Location

1100.1486.3302B Boehringer Ingelheim Investigational Site

Toulouse, France

Location

1100.1486.3302C Boehringer Ingelheim Investigational Site

Toulouse, France

Location

1100.1486.3310A Boehringer Ingelheim Investigational Site

Villeneuve-Saint-Georges, France

Location

1100.1486.4902 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1100.1486.4928 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1100.1486.4932 Boehringer Ingelheim Investigational Site

Bochum, Germany

Location

1100.1486.4922 Boehringer Ingelheim Investigational Site

Bonn, Germany

Location

1100.1486.4907 Boehringer Ingelheim Investigational Site

Cologne, Germany

Location

1100.1486.4924 Boehringer Ingelheim Investigational Site

Cologne, Germany

Location

1100.1486.4911 Boehringer Ingelheim Investigational Site

Dortmund, Germany

Location

1100.1486.4919 Boehringer Ingelheim Investigational Site

Düsseldorf, Germany

Location

1100.1486.4908 Boehringer Ingelheim Investigational Site

Erlangen, Germany

Location

1100.1486.4906 Boehringer Ingelheim Investigational Site

Essen, Germany

Location

1100.1486.4926 Boehringer Ingelheim Investigational Site

Frankfurt, Germany

Location

1100.1486.4916 Boehringer Ingelheim Investigational Site

Frankfurt am Main, Germany

Location

1100.1486.4929 Boehringer Ingelheim Investigational Site

Frankfurt am Main, Germany

Location

1100.1486.4901 Boehringer Ingelheim Investigational Site

Freiburg im Breisgau, Germany

Location

1100.1486.4930 Boehringer Ingelheim Investigational Site

Freiburg im Breisgau, Germany

Location

1100.1486.4909 Boehringer Ingelheim Investigational Site

Hamburg, Germany

Location

1100.1486.4920 Boehringer Ingelheim Investigational Site

Hamburg, Germany

Location

1100.1486.4925 Boehringer Ingelheim Investigational Site

Hamburg, Germany

Location

1100.1486.4915 Boehringer Ingelheim Investigational Site

Hanover, Germany

Location

1100.1486.4923 Boehringer Ingelheim Investigational Site

Hanover, Germany

Location

1100.1486.4910 Boehringer Ingelheim Investigational Site

Kiel, Germany

Location

1100.1486.4927 Boehringer Ingelheim Investigational Site

Mainz, Germany

Location

1100.1486.4903 Boehringer Ingelheim Investigational Site

München, Germany

Location

1100.1486.4904 Boehringer Ingelheim Investigational Site

München, Germany

Location

1100.1486.4912 Boehringer Ingelheim Investigational Site

München, Germany

Location

1100.1486.4905 Boehringer Ingelheim Investigational Site

Münster, Germany

Location

1100.1486.4918 Boehringer Ingelheim Investigational Site

Osnabrück, Germany

Location

1100.1486.4913 Boehringer Ingelheim Investigational Site

Ulm/Donau, Germany

Location

1100.1486.4914 Boehringer Ingelheim Investigational Site

Würzburg, Germany

Location

1100.1486.3531 Boehringer Ingelheim Investigational Site

Dublin, Ireland

Location

1100.1486.3532 Boehringer Ingelheim Investigational Site

Dublin, Ireland

Location

1100.1486.3908 Boehringer Ingelheim Investigational Site

Palermo, Italy

Location

1100.1486.3905 Boehringer Ingelheim Investigational Site

Pescara, Italy

Location

1100.1486.3901 Boehringer Ingelheim Investigational Site

Torino, Italy

Location

1100.1486.3907 Boehringer Ingelheim Investigational Site

Treviso, Italy

Location

1100.1486.3906 Boehringer Ingelheim Investigational Site

Verbania, Italy

Location

1100.1486.5207 Boehringer Ingelheim Investigational Site

Guadalajara, Mexico

Location

1100.1486.5204 Boehringer Ingelheim Investigational Site

León, Mexico

Location

1100.1486.3107 Boehringer Ingelheim Investigational Site

Amsterdam, Netherlands

Location

1100.1486.3103 Boehringer Ingelheim Investigational Site

Arnhem, Netherlands

Location

1100.1486.3101 Boehringer Ingelheim Investigational Site

Rotterdam, Netherlands

Location

1100.1486.3102 Boehringer Ingelheim Investigational Site

Zwolle, Netherlands

Location

1100.1486.4803 Boehringer Ingelheim Investigational Site

Bydgoszcz, Poland

Location

1100.1486.4801 Boehringer Ingelheim Investigational Site

Chorzów, Poland

Location

1100.1486.4804 Boehringer Ingelheim Investigational Site

Warsaw, Poland

Location

1100.1486.3503 Boehringer Ingelheim Investigational Site

Amadora, Portugal

Location

1100.1486.3501 Boehringer Ingelheim Investigational Site

Lisbon, Portugal

Location

1100.1486.3504 Boehringer Ingelheim Investigational Site

Lisbon, Portugal

Location

1100.1486.0024 Boehringer Ingelheim Investigational Site

Ponce, Puerto Rico

Location

1100.1486.0033 Boehringer Ingelheim Investigational Site

San Juan, Puerto Rico

Location

1100.1486.4001 Boehringer Ingelheim Investigational Site

Bucharest, Romania

Location

1100.1486.4002 Boehringer Ingelheim Investigational Site

Bucharest, Romania

Location

1100.1486.7002 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1100.1486.7001 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1100.1486.2707 Boehringer Ingelheim Investigational Site

Bloemfontein, South Africa

Location

1100.1486.2712 Boehringer Ingelheim Investigational Site

Bloemfontein, South Africa

Location

1100.1486.2703 Boehringer Ingelheim Investigational Site

Cape Town, South Africa

Location

1100.1486.2709 Boehringer Ingelheim Investigational Site

Cape Town, South Africa

Location

1100.1486.2711 Boehringer Ingelheim Investigational Site

Cape Town, South Africa

Location

1100.1486.2701 Boehringer Ingelheim Investigational Site

Edenvale, South Africa

Location

1100.1486.2710 Boehringer Ingelheim Investigational Site

Johannesburg, South Africa

Location

1100.1486.2706 Boehringer Ingelheim Investigational Site

Mbombela, South Africa

Location

1100.1486.2702 Boehringer Ingelheim Investigational Site

Port Elizabeth, South Africa

Location

1100.1486.2704 Boehringer Ingelheim Investigational Site

Pretoria, South Africa

Location

1100.1486.3406 Boehringer Ingelheim Investigational Site

Alcalá de Henares (Madrid), Spain

Location

1100.1486.3401 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1100.1486.3402 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1100.1486.3410 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1100.1486.3415 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1100.1486.3417 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1100.1486.3404 Boehringer Ingelheim Investigational Site

L'Hospitalet de Llobregat, Spain

Location

1100.1486.3403 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1100.1486.3405 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1100.1486.3407 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1100.1486.3414 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1100.1486.3416 Boehringer Ingelheim Investigational Site

Mataró, Spain

Location

1100.1486.3408 Boehringer Ingelheim Investigational Site

Valencia, Spain

Location

1100.1486.4101 Boehringer Ingelheim Investigational Site

Basel, Switzerland

Location

1100.1486.4109 Boehringer Ingelheim Investigational Site

Bern, Switzerland

Location

1100.1486.4107 Boehringer Ingelheim Investigational Site

Geneva, Switzerland

Location

1100.1486.4106 Boehringer Ingelheim Investigational Site

La Chaux-de-Fonds, Switzerland

Location

1100.1486.4104 Boehringer Ingelheim Investigational Site

Lausanne, Switzerland

Location

1100.1486.4102 Boehringer Ingelheim Investigational Site

Lugano, Switzerland

Location

1100.1486.4108 Boehringer Ingelheim Investigational Site

Sankt Gallen, Switzerland

Location

1100.1486.4110 Boehringer Ingelheim Investigational Site

Zurich, Switzerland

Location

1100.1486.4406 Boehringer Ingelheim Investigational Site

Birmingham, United Kingdom

Location

1100.1486.4403 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

1100.1486.4404 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

1100.1486.4405 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

1100.1486.4407 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

1100.1486.4401 Boehringer Ingelheim Investigational Site

Manchester, United Kingdom

Location

1100.1486.4408 Boehringer Ingelheim Investigational Site

Manchester, United Kingdom

Location

1100.1486.4402 Boehringer Ingelheim Investigational Site

Plaistow, London, United Kingdom

Location

Related Publications (1)

• Gathe J, Andrade-Villanueva J, Santiago S, Horban A, Nelson M, Cahn P, Bogner J, Spencer D, Podzamczer D, Yong CL, Nguyen T, Zhang W, Drulak M, Quinson AM. Efficacy and safety of nevirapine extended-release once daily versus nevirapine immediate-release twice-daily in treatment-naive HIV-1-infected patients. Antivir Ther. 2011;16(5):759-69. doi: 10.3851/IMP1803.

  PMID: 21817198 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Nevirapine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

For the lead-in-period with NVP IR 200mg QD, MedDRA Version 12.1 was used for AE/SAE reporting.

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2007
• First Posted: November 21, 2007
• Study Start: November 1, 2007
• Primary Completion: November 1, 2011
• Last Updated: April 7, 2014
• Results First Posted: January 19, 2012

Record last verified: 2014-03

Locations

PR (2); IT (5); US (41); RO (2); RU (2); ZA (10); CH (8); GB (8); FR (36); PL (3); ES (13); AR (8); CA (8); BE (9); DE (29); AU (4); PT (3); ME (2); BO (3); NL (4); IE (2)