An open label, phase IIIb, randomized parallel group study to assess the efficacy and safety of switching HIV-1 infected patients successfully treated with a Nevirapine IR based regimen to Nevirapine XR 400 mg QD or remaining on Nevirapine IR 200 mg BIDbased regime
- Conditions
- The patients for this trial are to be antiretroviral treatment-experienced, currently receiving nevirapine IR 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 undetectable HIV-1 viral load, provided that the limit of detection of the test is below 100 copies/mL.All patients need to be on stable therapy with Nevirapine for at least 18 weeks with a viral load of < 50 copies/mL.Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2008-004681-55-DE
- Lead Sponsor
- Boehringer Ingelheim Pharma GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
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. Patients without documented
proceeding Western Blot for HIV may undergo testing at screening.
3. Treatment with Viramune regimen for at least the preceding 18 weeks.
4. Background therapy with one of the following for the previous 18 weeks:
3TC/ABC (Kivexa® in EU; Epzicom in US), FTC/TDF (Truvada™) or 3TC/AZT
(Combivir®). The combination drug may also be given as separate components. No
other anti-retrovirals may be given in addition to nevirapne and background at the
time of screening.
5. An undetectable HIV viral load in the preceding 1-4 months, provided that the
limit of detection of the test is below 100 copies/mL.
6. An HIV viral load of < 50 copies/mL at screening (Visit 1).
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 (listed in Appendix 10.4).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 415
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
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, 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method