Phase 3
Completed N=1,068
VERxVE Study on Efficacy and Safety of Nevirapine XR in Comparison to Nevirapine IR With Truvada in Naive HIV+ Patients
Source: ClinicalTrials.gov NCT00561925 ↗Enrolled (actual)
1,068
Serious AEs
8.6%
Results posted
Jan 2012
Primary outcomePrimary: Comparison of Proportion of Virologic Response at Week 48 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population — 384; 409; 122; 96 participants — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of Proportion of Virologic Response at Week 48 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population |
384; 409; 122; 96 | <0.0001 sig |
| SECONDARY 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 |
1; 1; 0.84; 0.865; 0.838; 0.865 | — |
| SECONDARY Proportion of Sustained Virologic Response at Week 144 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population |
296; 321; 210; 184 | <0.0001 sig |
| SECONDARY Kaplan-Meier Estimates for Time to New AIDS or AIDS-related Progression Event or Death, Full Analysis Set Population |
0; 0; 0.006; 0.002; 0.006; 0.006 | — |
| SECONDARY Comparison of HIV-1 Viral Load (log10 Copies/mL) Change From Baseline at Week 144, Full Analysis Set Population |
-2.7; -2.8 | 0.7719 |
| SECONDARY Comparison of CD4+ Cell Count (Cells/Cubic Millimeter) Change From Baseline at Week 144, Full Analysis Set Population |
239.3; 270.7 | 0.0078 sig |
| SECONDARY Occurrence of Rashes |
9; 11; 6; 0; 6; 13 | — |
| SECONDARY Occurrence of Elevations in Laboratory Measurement by DAIDS Grade |
53; 111; 71; 8; 17; 25 | — |
| SECONDARY Kaplan -Meier Estimate of Cumulative Probability of Permanent Discontinuation of Study Medication |
0.000; 0.000; 0.000; 0.000; 0.034; 0.026 | — |
| SECONDARY Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 ALT/AST Abnormalities |
0.000; 0.000; 0.000; 0.002; 0.012; 0.014 | — |
| SECONDARY Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 Asymptotic Transaminases Abnormalities |
0.000; 0.000; 0.000; 0.000; 0.006; 0.002 | — |
| SECONDARY Kaplan -Meier Estimate of Cumulative Probability of Clinical Hepatic Events |
0.000; 0.000; 0.000; 0.002; 0.012; 0.010 | — |
| SECONDARY Kaplan -Meier Estimate of Cumulative Probability of Group III or IV Drug-related Rash |
0.000; 0.000; 0.000; 0.000; 0.002; 0.006 | — |
| SECONDARY Relative Bioavailability Trough C_pre,ss,1 |
4567.03; 3634.26 | 0.5542 |
| SECONDARY Occurrence of Hepatic Events |
10; 8; 2; 0 | — |
Eligibility Criteria
Inclusion criteria
- 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 - 50- 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.
Exclusion criteria
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT00561925). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.