HIV InfectionsPhase 3NCT00561925

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

A Phase 3 study testing nevirapine IR and nevirapine XR in people with HIV Infections, run by Boehringer Ingelheim at 202 sites in 21 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Infections
What is being tested?: nevirapine IR and nevirapine XR
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,068 participants
Where: 202 sitesin 21 countries
Study dates: Nov 2007to Nov 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

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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.
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.

Who cannot join

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

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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

Trial locations and contacts

202 sites in 21 countries.

Country

City, postcode or hospital

202 sites in 21 countries

United States41 sites

1100.1486.0005 Boehringer Ingelheim Investigational Site
Akron, Ohio
1100.1486.0046 Boehringer Ingelheim Investigational Site
Annandale, Virginia
1100.1486.0031 Boehringer Ingelheim Investigational Site
Atlanta, Georgia
1100.1486.0004 Boehringer Ingelheim Investigational Site
Austin, Texas
1100.1486.0017 Boehringer Ingelheim Investigational Site
Bakersfield, California
1100.1486.0019 Boehringer Ingelheim Investigational Site
Berkley, Michigan
1100.1486.0001 Boehringer Ingelheim Investigational Site
Beverly Hills, California
1100.1486.0057 Boehringer Ingelheim Investigational Site
Beverly Hills, California
1100.1486.0059 Boehringer Ingelheim Investigational Site
Beverly Hills, California
1100.1486.0040 Boehringer Ingelheim Investigational Site
Birmingham, Alabama
1100.1486.0053 Boehringer Ingelheim Investigational Site
Boise, Idaho
1100.1486.0055 Boehringer Ingelheim Investigational Site
Charlotte, North Carolina
1100.1486.0002 Boehringer Ingelheim Investigational Site
Chicago, Illinois
1100.1486.0026 Boehringer Ingelheim Investigational Site
Chicago, Illinois
1100.1486.0037 Boehringer Ingelheim Investigational Site
Clearwater, Florida
1100.1486.0018 Boehringer Ingelheim Investigational Site
Dallas, Texas
1100.1486.0038 Boehringer Ingelheim Investigational Site
Dallas, Texas
1100.1486.0043 Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida
1100.1486.0044 Boehringer Ingelheim Investigational Site
Fort Worth, Texas
1100.1486.0054 Boehringer Ingelheim Investigational Site
Harlingen, Texas
1100.1486.0009 Boehringer Ingelheim Investigational Site
Houston, Texas
1100.1486.0003 Boehringer Ingelheim Investigational Site
Huntersville, North Carolina
1100.1486.0006 Boehringer Ingelheim Investigational Site
Kansas City, Missouri
1100.1486.0020 Boehringer Ingelheim Investigational Site
Lexington, Kentucky
1100.1486.0035 Boehringer Ingelheim Investigational Site
Long Beach, California
1100.1486.0025 Boehringer Ingelheim Investigational Site
Los Angeles, California
1100.1486.0034 Boehringer Ingelheim Investigational Site
Los Angeles, California
1100.1486.0041 Boehringer Ingelheim Investigational Site
Los Angeles, California
1100.1486.0010 Boehringer Ingelheim Investigational Site
Macon, Georgia
1100.1486.0012 Boehringer Ingelheim Investigational Site
Miami, Florida
1100.1486.0007 Boehringer Ingelheim Investigational Site
Miami Beach, Florida
1100.1486.0039 Boehringer Ingelheim Investigational Site
Orlando, Florida
1100.1486.0013 Boehringer Ingelheim Investigational Site
Phoenix, Arizona
1100.1486.0032 Boehringer Ingelheim Investigational Site
Sacramento, California
1100.1486.0028 Boehringer Ingelheim Investigational Site
San Diego, California
1100.1486.0027 Boehringer Ingelheim Investigational Site
St Louis, Missouri
1100.1486.0050 Boehringer Ingelheim Investigational Site
Vero Beach, Florida
1100.1486.0023 Boehringer Ingelheim Investigational Site
Washington D.C., District of Columbia
1100.1486.0029 Boehringer Ingelheim Investigational Site
Washington D.C., District of Columbia
1100.1486.0048 Boehringer Ingelheim Investigational Site
Washington D.C., District of Columbia
1100.1486.0014 Boehringer Ingelheim Investigational Site
Wilton Manors, Florida

Other trials in United States

France36 sites

1100.1486.3305A Boehringer Ingelheim Investigational Site
Angers
1100.1486.3305B Boehringer Ingelheim Investigational Site
Angers
1100.1486.3307A Boehringer Ingelheim Investigational Site
Bondy
1100.1486.3317A Boehringer Ingelheim Investigational Site
Bordeaux
1100.1486.3316A Boehringer Ingelheim Investigational Site
Brest
1100.1486.3316B Boehringer Ingelheim Investigational Site
Brest
1100.1486.3314E Boehringer Ingelheim Investigational Site
Caen
1100.1486.3304A Boehringer Ingelheim Investigational Site
Clamart
1100.1486.3308A Boehringer Ingelheim Investigational Site
Lyon
1100.1486.3308C Boehringer Ingelheim Investigational Site
Lyon
1100.1486.3301A Boehringer Ingelheim Investigational Site
Nantes
1100.1486.3301B Boehringer Ingelheim Investigational Site
Nantes
1100.1486.3301C Boehringer Ingelheim Investigational Site
Nantes
1100.1486.3301D Boehringer Ingelheim Investigational Site
Nantes
1100.1486.3301E Boehringer Ingelheim Investigational Site
Nantes
1100.1486.3301F Boehringer Ingelheim Investigational Site
Nantes
1100.1486.3301G Boehringer Ingelheim Investigational Site
Nantes
1100.1486.3301H Boehringer Ingelheim Investigational Site
Nantes
1100.1486.3301I Boehringer Ingelheim Investigational Site
Nantes
1100.1486.3306A Boehringer Ingelheim Investigational Site
Nice
1100.1486.3303A Boehringer Ingelheim Investigational Site
Paris
1100.1486.3303B Boehringer Ingelheim Investigational Site
Paris
1100.1486.3303C Boehringer Ingelheim Investigational Site
Paris
1100.1486.3303D Boehringer Ingelheim Investigational Site
Paris
1100.1486.3312A Boehringer Ingelheim Investigational Site
Paris
1100.1486.3312B Boehringer Ingelheim Investigational Site
Paris
1100.1486.3309A Boehringer Ingelheim Investigational Site
Saint-Etienne
1100.1486.3309B Boehringer Ingelheim Investigational Site
Saint-Etienne
1100.1486.3318A Boehringer Ingelheim Investigational Site
Toulon
1100.1486.3318B Boehringer Ingelheim Investigational Site
Toulon
1100.1486.3318C Boehringer Ingelheim Investigational Site
Toulon
1100.1486.3318D Boehringer Ingelheim Investigational Site
Toulon
1100.1486.3302A Boehringer Ingelheim Investigational Site
Toulouse
1100.1486.3302B Boehringer Ingelheim Investigational Site
Toulouse
1100.1486.3302C Boehringer Ingelheim Investigational Site
Toulouse
1100.1486.3310A Boehringer Ingelheim Investigational Site
Villeneuve-Saint-Georges

Other trials in France

Germany29 sites

1100.1486.4902 Boehringer Ingelheim Investigational Site
Berlin
1100.1486.4928 Boehringer Ingelheim Investigational Site
Berlin
1100.1486.4932 Boehringer Ingelheim Investigational Site
Bochum
1100.1486.4922 Boehringer Ingelheim Investigational Site
Bonn
1100.1486.4907 Boehringer Ingelheim Investigational Site
Cologne
1100.1486.4924 Boehringer Ingelheim Investigational Site
Cologne
1100.1486.4911 Boehringer Ingelheim Investigational Site
Dortmund
1100.1486.4919 Boehringer Ingelheim Investigational Site
Düsseldorf
1100.1486.4908 Boehringer Ingelheim Investigational Site
Erlangen
1100.1486.4906 Boehringer Ingelheim Investigational Site
Essen
1100.1486.4926 Boehringer Ingelheim Investigational Site
Frankfurt
1100.1486.4916 Boehringer Ingelheim Investigational Site
Frankfurt am Main
1100.1486.4929 Boehringer Ingelheim Investigational Site
Frankfurt am Main
1100.1486.4901 Boehringer Ingelheim Investigational Site
Freiburg im Breisgau
1100.1486.4930 Boehringer Ingelheim Investigational Site
Freiburg im Breisgau
1100.1486.4909 Boehringer Ingelheim Investigational Site
Hamburg
1100.1486.4920 Boehringer Ingelheim Investigational Site
Hamburg
1100.1486.4925 Boehringer Ingelheim Investigational Site
Hamburg
1100.1486.4915 Boehringer Ingelheim Investigational Site
Hanover
1100.1486.4923 Boehringer Ingelheim Investigational Site
Hanover
1100.1486.4910 Boehringer Ingelheim Investigational Site
Kiel
1100.1486.4927 Boehringer Ingelheim Investigational Site
Mainz
1100.1486.4903 Boehringer Ingelheim Investigational Site
München
1100.1486.4904 Boehringer Ingelheim Investigational Site
München
1100.1486.4912 Boehringer Ingelheim Investigational Site
München
1100.1486.4905 Boehringer Ingelheim Investigational Site
Münster
1100.1486.4918 Boehringer Ingelheim Investigational Site
Osnabrück
1100.1486.4913 Boehringer Ingelheim Investigational Site
Ulm/Donau
1100.1486.4914 Boehringer Ingelheim Investigational Site
Würzburg

Other trials in Germany

Spain13 sites

1100.1486.3406 Boehringer Ingelheim Investigational Site
Alcalá de Henares (Madrid)
1100.1486.3401 Boehringer Ingelheim Investigational Site
Barcelona
1100.1486.3402 Boehringer Ingelheim Investigational Site
Barcelona
1100.1486.3410 Boehringer Ingelheim Investigational Site
Barcelona
1100.1486.3415 Boehringer Ingelheim Investigational Site
Barcelona
1100.1486.3417 Boehringer Ingelheim Investigational Site
Barcelona
1100.1486.3404 Boehringer Ingelheim Investigational Site
L'Hospitalet de Llobregat
1100.1486.3403 Boehringer Ingelheim Investigational Site
Madrid
1100.1486.3405 Boehringer Ingelheim Investigational Site
Madrid
1100.1486.3407 Boehringer Ingelheim Investigational Site
Madrid
1100.1486.3414 Boehringer Ingelheim Investigational Site
Madrid
1100.1486.3416 Boehringer Ingelheim Investigational Site
Mataró
1100.1486.3408 Boehringer Ingelheim Investigational Site
Valencia

Other trials in Spain

South Africa10 sites

1100.1486.2707 Boehringer Ingelheim Investigational Site
Bloemfontein
1100.1486.2712 Boehringer Ingelheim Investigational Site
Bloemfontein
1100.1486.2703 Boehringer Ingelheim Investigational Site
Cape Town
1100.1486.2709 Boehringer Ingelheim Investigational Site
Cape Town
1100.1486.2711 Boehringer Ingelheim Investigational Site
Cape Town
1100.1486.2701 Boehringer Ingelheim Investigational Site
Edenvale
1100.1486.2710 Boehringer Ingelheim Investigational Site
Johannesburg
1100.1486.2706 Boehringer Ingelheim Investigational Site
Mbombela
1100.1486.2702 Boehringer Ingelheim Investigational Site
Port Elizabeth
1100.1486.2704 Boehringer Ingelheim Investigational Site
Pretoria

Other trials in South Africa

Belgium9 sites

1100.1486.3208 Boehringer Ingelheim Investigational Site
Bruges
1100.1486.3201 Boehringer Ingelheim Investigational Site
Brussels
1100.1486.3203 Boehringer Ingelheim Investigational Site
Brussels
1100.1486.3205 Boehringer Ingelheim Investigational Site
Brussels
1100.1486.3207 Boehringer Ingelheim Investigational Site
Brussels
1100.1486.3209 Boehringer Ingelheim Investigational Site
Charleroi
1100.1486.3202 Boehringer Ingelheim Investigational Site
Ghent
1100.1486.3204 Boehringer Ingelheim Investigational Site
Liège
1100.1486.3206 Boehringer Ingelheim Investigational Site
Liège

Other trials in Belgium

Argentina8 sites

1100.1486.5401 Boehringer Ingelheim Investigational Site
Capital Federal
1100.1486.5402 Boehringer Ingelheim Investigational Site
Capital Federal
1100.1486.5404 Boehringer Ingelheim Investigational Site
Capital Federal
1100.1486.5407 Boehringer Ingelheim Investigational Site
Capital Federal
1100.1486.5408 Boehringer Ingelheim Investigational Site
Capital Federal
1100.1486.5403 Boehringer Ingelheim Investigational Site
Mar del Plata
1100.1486.5409 Boehringer Ingelheim Investigational Site
Quilmes
1100.1486.5405 Boehringer Ingelheim Investigational Site
Rosario

Other trials in Argentina

Canada8 sites

1100.1486.1005 Boehringer Ingelheim Investigational Site
Montreal, Quebec
1100.1486.1010 Boehringer Ingelheim Investigational Site
Montreal, Quebec
1100.1486.1014 Boehringer Ingelheim Investigational Site
Montreal, Quebec
1100.1486.1011 Boehringer Ingelheim Investigational Site
Quebec (Ste Foy), Quebec
1100.1486.1013 Boehringer Ingelheim Investigational Site
Toronto, Ontario
1100.1486.1016 Boehringer Ingelheim Investigational Site
Toronto, Ontario
1100.1486.1002 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia
1100.1486.1004 Boehringer Ingelheim Investigational Site
Winnipeg, Manitoba

Other trials in Canada

Switzerland8 sites

1100.1486.4101 Boehringer Ingelheim Investigational Site
Basel
1100.1486.4109 Boehringer Ingelheim Investigational Site
Bern
1100.1486.4107 Boehringer Ingelheim Investigational Site
Geneva
1100.1486.4106 Boehringer Ingelheim Investigational Site
La Chaux-de-Fonds
1100.1486.4104 Boehringer Ingelheim Investigational Site
Lausanne
1100.1486.4102 Boehringer Ingelheim Investigational Site
Lugano
1100.1486.4108 Boehringer Ingelheim Investigational Site
Sankt Gallen
1100.1486.4110 Boehringer Ingelheim Investigational Site
Zurich

Other trials in Switzerland

United Kingdom8 sites

1100.1486.4406 Boehringer Ingelheim Investigational Site
Birmingham
1100.1486.4403 Boehringer Ingelheim Investigational Site
London
1100.1486.4404 Boehringer Ingelheim Investigational Site
London
1100.1486.4405 Boehringer Ingelheim Investigational Site
London
1100.1486.4407 Boehringer Ingelheim Investigational Site
London
1100.1486.4401 Boehringer Ingelheim Investigational Site
Manchester
1100.1486.4408 Boehringer Ingelheim Investigational Site
Manchester
1100.1486.4402 Boehringer Ingelheim Investigational Site
Plaistow, London

Other trials in United Kingdom

Italy5 sites

1100.1486.3908 Boehringer Ingelheim Investigational Site
Palermo
1100.1486.3905 Boehringer Ingelheim Investigational Site
Pescara
1100.1486.3901 Boehringer Ingelheim Investigational Site
Torino
1100.1486.3907 Boehringer Ingelheim Investigational Site
Treviso
1100.1486.3906 Boehringer Ingelheim Investigational Site
Verbania

Other trials in Italy

Australia4 sites

1100.1486.6103 Boehringer Ingelheim Investigational Site
Brisbane, Queensland
1100.1486.6101 Boehringer Ingelheim Investigational Site
Darlinghurst, New South Wales
1100.1486.6102 Boehringer Ingelheim Investigational Site
Darlinghurst, New South Wales
1100.1486.6104 Boehringer Ingelheim Investigational Site
Surry Hills, New South Wales

Other trials in Australia

Netherlands4 sites

1100.1486.3107 Boehringer Ingelheim Investigational Site
Amsterdam
1100.1486.3103 Boehringer Ingelheim Investigational Site
Arnhem
1100.1486.3101 Boehringer Ingelheim Investigational Site
Rotterdam
1100.1486.3102 Boehringer Ingelheim Investigational Site
Zwolle

Other trials in Netherlands

Botswana3 sites

1100.1486.2605 Boehringer Ingelheim Investigational Site
Francistown
1100.1486.2601 Boehringer Ingelheim Investigational Site
Gaborone
1100.1486.2603 Boehringer Ingelheim Investigational Site
Gaborone

Other trials in Botswana

Poland3 sites

1100.1486.4803 Boehringer Ingelheim Investigational Site
Bydgoszcz
1100.1486.4801 Boehringer Ingelheim Investigational Site
Chorzów
1100.1486.4804 Boehringer Ingelheim Investigational Site
Warsaw

Other trials in Poland

Portugal3 sites

1100.1486.3503 Boehringer Ingelheim Investigational Site
Amadora
1100.1486.3501 Boehringer Ingelheim Investigational Site
Lisbon
1100.1486.3504 Boehringer Ingelheim Investigational Site
Lisbon

Other trials in Portugal

Ireland2 sites

1100.1486.3531 Boehringer Ingelheim Investigational Site
Dublin
1100.1486.3532 Boehringer Ingelheim Investigational Site
Dublin

Other trials in Ireland

Mexico2 sites

1100.1486.5207 Boehringer Ingelheim Investigational Site
Guadalajara
1100.1486.5204 Boehringer Ingelheim Investigational Site
León

Other trials in Mexico

Puerto Rico2 sites

1100.1486.0024 Boehringer Ingelheim Investigational Site
Ponce
1100.1486.0033 Boehringer Ingelheim Investigational Site
San Juan

Other trials in Puerto Rico

Romania2 sites

1100.1486.4001 Boehringer Ingelheim Investigational Site
Bucharest
1100.1486.4002 Boehringer Ingelheim Investigational Site
Bucharest

Other trials in Romania

Russia2 sites

1100.1486.7002 Boehringer Ingelheim Investigational Site
Moscow
1100.1486.7001 Boehringer Ingelheim Investigational Site
Saint Petersburg

Other trials in Russia

About this study

Official title: A Randomised, Double Blind, Double Dummy, Parallel Group, Active Controlled Trial to Evaluate the Antiviral Efficacy of 400 mg QD neVirapine Extended Release Formulation in Comparison to 200 mg BID neVirapinE Immediate Release in Combination With Truvada® in Antiretroviral Therapy naïve HIV-1 Infected Patients (VERxVE)

Conditions: HIV Infections
Being tested: nevirapine IR, nevirapine XR
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

nevirapine IRDrug
200 mg BID
nevirapine XRDrug
400 mg QD

Study groups in NCT00561925
Study group	Role	What they receive
nevirapine XR	Experimental	400 mg QD Receives: Drug: nevirapine XR
nevirapine IR	Active comparator	200 mg BID Receives: Drug: nevirapine IR

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
Endpoint was the number of patients with a sustained virologic response through week 144 using LLOQ = 50 copies/mL
Measured: week 144
Kaplan-Meier Estimates for Time to New AIDS or AIDS-related Progression Event or Death, Full Analysis Set Population
Measured: week 0 to 144
Comparison of HIV-1 Viral Load (log10 Copies/mL) Change From Baseline at Week 144, Full Analysis Set Population
Measured: baseline, week 144
Comparison of CD4+ Cell Count (Cells/Cubic Millimeter) Change From Baseline at Week 144, Full Analysis Set Population
Measured: baseline, week 144
Occurrence of Rashes
Frequency of patients with drug related rash events by functional grouping
Measured: until last patient completed 144 weeks (up to 193 weeks)
Occurrence of Elevations in Laboratory Measurement by DAIDS Grade
Measured: until last patient completed 144 weeks (up to 193 weeks)
Kaplan -Meier Estimate of Cumulative Probability of Permanent Discontinuation of Study Medication
Measured: week 0 to 144
Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 ALT/AST Abnormalities
Measured: week 0 to 72
Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 Asymptotic Transaminases Abnormalities
Measured: week 0 to 72
Kaplan -Meier Estimate of Cumulative Probability of Clinical Hepatic Events
Measured: week 0 to 72
Kaplan -Meier Estimate of Cumulative Probability of Group III or IV Drug-related Rash
Measured: week 0 to 72
Relative Bioavailability Trough C_pre,ss,1
Relative bioavailability measured of trough concentrations. Analysis based on adjusted by-treatment geometric means, the adjusted geometric mean ratio of NVP XR : NVP IR and it's 90% confidence interval with p-value and the inter-individual geometric coefficient of variation.
Measured: week 132
Occurrence of Hepatic Events
Frequency of patients with hepatitis symptoms
Measured: until last patient completed 144 weeks (up to 193 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2007Nov 2011

First posted21 Nov 2007 (estimated)
Study startNov 2007
Primary completionNov 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 1,068 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00561925
Sponsor's protocol ID: 1100.1486
Other IDs: 2007-003654-29
Status last verified: Mar 2014
First submitted: 20 Nov 2007
Last updated: 7 Apr 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 21817198

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double Blind, Double Dummy, Parallel Group, Active Controlled Trial to Evaluate the Antiviral Efficacy of 400 mg QD neVirapine Extended Release Formulation in Comparison to 200 mg BID neVirapinE Immediate Release in Combination With Truvada® in Antiretroviral Therapy naïve HIV-1 Infected Patients (VERxVE)
ClinicalTrials.gov ID: NCT00561925
Acronym / sponsor ID: 1100.1486
Conditions: HIV Infections
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,068 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Nov 2007
Primary completion: Nov 2011 (actual)
First posted: 21 Nov 2007 (estimated)
Results: Posted 19 Jan 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 2

Arm	Type	Receives
nevirapine XR	Experimental	Drug: nevirapine XR400 mg QD
nevirapine IR	Active comparator	Drug: nevirapine IR200 mg BID

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

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:

Key exclusion criteria (15 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
nevirapine IR200 mg BID	Drug	nevirapine IR
nevirapine XR400 mg QD	Drug	nevirapine XR

Primary outcome

Comparison of Proportion of Virologic Response at Week 48 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Time frame: week 48
Primary endpoint was the number of patients with a sustained virologic response through week 48 using LLOQ = 50 copies/mL

14 secondary outcomes

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
Time frame: 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
Time frame: week 144
Kaplan-Meier Estimates for Time to New AIDS or AIDS-related Progression Event or Death, Full Analysis Set Population
Time frame: week 0 to 144
Comparison of HIV-1 Viral Load (log10 Copies/mL) Change From Baseline at Week 144, Full Analysis Set Population
Time frame: baseline, week 144
Comparison of CD4+ Cell Count (Cells/Cubic Millimeter) Change From Baseline at Week 144, Full Analysis Set Population
Time frame: baseline, week 144
Occurrence of Rashes
Time frame: until last patient completed 144 weeks (up to 193 weeks)
Occurrence of Elevations in Laboratory Measurement by DAIDS Grade
Time frame: until last patient completed 144 weeks (up to 193 weeks)
Kaplan -Meier Estimate of Cumulative Probability of Permanent Discontinuation of Study Medication
Time frame: week 0 to 144
Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 ALT/AST Abnormalities
Time frame: week 0 to 72
Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 Asymptotic Transaminases Abnormalities
Time frame: week 0 to 72
Kaplan -Meier Estimate of Cumulative Probability of Clinical Hepatic Events
Time frame: week 0 to 72
Kaplan -Meier Estimate of Cumulative Probability of Group III or IV Drug-related Rash
Time frame: week 0 to 72
Relative Bioavailability Trough C_pre,ss,1
Time frame: week 132
Occurrence of Hepatic Events
Time frame: until last patient completed 144 weeks (up to 193 weeks)

Results and safety

Results posted to the registry on 19 Jan 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NVP IR 200mg QD	1,068	1,013
NVP IR 200mg BID	0	0
NVP XR 400mg QD	0	0
NVP XR	0	0
NVP IR to XR	0	0

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

Time frame: week 48. Number. Unit: participants

Measure	NVP IR 200mg QD n = 0	NVP IR 200mg BID n = 506	NVP XR 400mg QD n = 505
Responder	–	384	409
Non responder	–	122	96

NVP IR 200mg BID vs NVP XR 400mg QD: Cochran's statistic: 4.9 (95% CI -0.1 to 10.0), p <0.0001, Cochran's statistic

Population analysed: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 193 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NVP IR 200mg QD	20 of 1,068 (1.9%)	308 of 1,068 (28.8%)	Not reported
NVP IR	33 of 191 (17.3%)	131 of 191 (68.6%)	Not reported
NVP XR	93 of 505 (18.4%)	403 of 505 (79.8%)	Not reported
NVP IR-IR/XR	50 of 315 (15.9%)	271 of 315 (86%)	Not reported
NVP XR-IR/XR	9 of 315 (2.9%)	81 of 315 (25.7%)	Not reported

Limitations and caveats (from the sponsor): For the lead-in-period with NVP IR 200mg QD, MedDRA Version 12.1 was used for AE/SAE reporting.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21817198Gathe 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.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

202 sites in 21 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing nevirapine IR and nevirapine XR in people with HIV Infections, run by Boehringer Ingelheim at 202 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 202 sites in United States, France, Germany, Spain, South Africa and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of Proportion of Virologic Response at Week 48 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population (time frame: week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00561925, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2014.