E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The patients for this trial are to be HIV-1 infected, antiretroviral treatment-experienced, currently receiving nevirapine IR 200 mg BID with a background therapy of fixed-dose combination (FDC) of 3TC + ABC, FTC + TDF or 3TC + /AZT, men and women ≥ 18 years of age, with an HIV-1 viral load of ≤ 50 copies/mL. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this study is to demonstrate the efficacy of nevirapine extended release (NVP XR) based regimen for HIV-1 infected patients who were receiving nevirapine immediate release (NVP IR) based regimen for at least 18 prior weeks of therapy. |
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E.2.2 | Secondary objectives of the trial |
Secondary objective of this study is to assess the safety and tolerance of NVP XR based regimen for HIV-1 infected patients who were receiving NVP IR based regimen for at least 18 prior weeks of therapy. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
HIV infected subjects treated with a Viramune based regimen. A subject that meets the following inclusion criteria will be eligible for participation in this study: 1. Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation. 2. HIV-1 infected males or females ≥ 18 years. 3. Treatment with Viramune regimen for at least the preceding 18 weeks. 4. Background therapy with 3TC/ABC (Kivexa® in EU; Epzicom in US), FTC/TDF (Truvada™) or 3TC/AZT (Combivir®). 5. An HIV viral load < 50 copies/mL in preceding 3 months. 6. An HIV viral load of < 50 copies/mL at screening 7. Acceptable screening laboratory values that indicate adequate baseline organ function with the following exceptions: • ALT and AST < 2.5 × ULN (DAIDS Grade 1). 8. Willingness to abstain from ingesting medications that are listed as contraindicated in the SPC (or PI) or Investigator's Brochure during the study. 9. Karnofsky performance score of ≥ 70 |
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E.4 | Principal exclusion criteria |
Subjects who meet one or more of the following criteria will be excluded from the study: 1. Current treatment with an HIV protease inhibitor 2. Participation in another trial or use of an investigational medicine within two months prior to Day 1 of this study 3. Female patients of child-bearing potential who: a. Have a positive serum pregnancy test at screening. b. Are breast feeding. c. Are planning to become pregnant d. Are not willing to use a double-barrier methods (simultaneous use of two diffeent methods such as diaphragm with spermicidal substance and condom) of contraception, or require ethinyl estradiol administration. Barrier methods of contraception include diaphragm with spermicidal substance, condom for females, cervical caps and condoms.. 4. Laboratory parameters > DAIDS grade 2: • Coagulation (PT, PTT, INR) • Hematology (absolute platelets, WBC, absolute neutrophil count, hemoglobin) • Biochemistry (total bilirubin, amylase, serum creatinine, fasting glucose, lactate, alkaline phosphatase) 5. Laboratory parameters > DAIDS grade 3 • Total triglycerides (total cholesterol no restriction) 6. Hypersensitivity to any ingredients of the test products 7. Active drug abuse or chronic alcoholism. 8. Hepatic cirrhosis stage Child-Pugh B or C 9. History of severe or acute illness within 60 days prior to Day 1, malignancy or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the trial 10. Inability to comply with protocol requirements |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is proportion of sustained virologic response through Week 24. The time window of week 24 is defined as 24 weeks ± 4 weeks from Day 1. A patient will be considered as a treatment failure at the earliest time of any one of the following events prior to Week 24: • A virologic failure defined by viral load ≥ 50 copies/mL measured at two consecutive visits, at least two weeks apart. • Change of ARV therapy defined as use of new ARV therapy. • Death. • Lost to follow-up.
If the treatment failure is an unconfirmed VL ≥ 50 copies/mL in the Week 24 window, then another measurement two weeks later is necessary to confirm whether a virologic failure has occurred.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 12 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 33 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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An EOT visit will be performed when a patient either completes the entire trial at Week 144 or discontinues early. This visit should occur within one week of the last dose of study drug to evaluate efficacy, AEs/SAEs and the final laboratory test results. The EOT visit for early discontinuation is conducted to collect efficacy and safety information from patients who discontinue from Trial 1100.1526. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |