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

Phase 3

Completed

• Conditions: HIV Infections
• Interventions: Drug: nevirapine IR; Drug: nevirapine XR

• Registration Number: NCT00561925
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-11-20
• Study First Submitted QC: 2007-11-20
• Study First Posted: 2007-11-21
• Primary Completion: 2011-11
• Results First Submitted: 2011-12-13
• Results First Submitted QC: 2011-12-13
• Results First Posted: 2012-01-19
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-07
• Last Update Posted: 2014-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1068

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nevirapine IR	nevirapine IR	200 mg BID
nevirapine XR	nevirapine XR	400 mg QD

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Kaplan-Meier Estimates for Time to New AIDS or AIDS-related Progression Event or Death, Full Analysis Set Population	week 0 to 144
Occurrence of Rashes	until last patient completed 144 weeks (up to 193 weeks)	Frequency of patients with drug related rash events by functional grouping
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	Endpoint was the number of patients with a sustained virologic response through week 144 using LLOQ = 50 copies/mL
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
Occurrence of Elevations in Laboratory Measurement by DAIDS Grade	until last patient completed 144 weeks (up to 193 weeks)
Kaplan -Meier Estimate of Cumulative Probability of Permanent Discontinuation of Study Medication	week 0 to 144
Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 ALT/AST Abnormalities	week 0 to 72
Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 Asymptotic Transaminases Abnormalities	week 0 to 72
Kaplan -Meier Estimate of Cumulative Probability of Clinical Hepatic Events	week 0 to 72
Kaplan -Meier Estimate of Cumulative Probability of Group III or IV Drug-related Rash	week 0 to 72
Relative Bioavailability Trough C_pre,ss,1	week 132	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.
Occurrence of Hepatic Events	until last patient completed 144 weeks (up to 193 weeks)	Frequency of patients with hepatitis symptoms

Trial Locations

Locations (202)

1100.1486.0040 Boehringer Ingelheim Investigational Site; 🇺🇸 Birmingham, Alabama, United States

1100.1486.0013 Boehringer Ingelheim Investigational Site; 🇺🇸 Phoenix, Arizona, United States

1100.1486.0017 Boehringer Ingelheim Investigational Site; 🇺🇸 Bakersfield, California, United States

1100.1486.0001 Boehringer Ingelheim Investigational Site; 🇺🇸 Beverly Hills, California, United States

1100.1486.0057 Boehringer Ingelheim Investigational Site; 🇺🇸 Beverly Hills, California, United States

1100.1486.0059 Boehringer Ingelheim Investigational Site; 🇺🇸 Beverly Hills, California, United States

1100.1486.0035 Boehringer Ingelheim Investigational Site; 🇺🇸 Long Beach, California, United States

1100.1486.0025 Boehringer Ingelheim Investigational Site; 🇺🇸 Los Angeles, California, United States

1100.1486.0034 Boehringer Ingelheim Investigational Site; 🇺🇸 Los Angeles, California, United States

1100.1486.0041 Boehringer Ingelheim Investigational Site; 🇺🇸 Los Angeles, California, United States

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