A LONG-TERM OPEN-LABEL EXTENSION STUDY OF LERSIVIRINE FOR THE TREATMENT OF HIV-1 INFECTION - ND

• Register: EUCTR
• Last refreshed on: 25 March 2013
• Main ID: EUCTR2010-020860-39-IT
• Date of registration: 01/12/2010
• Prospective Registration: Yes
• Primary sponsor: Pfizer Inc., 235 East 42nd Street, New York, NY 10017
• Public title: A LONG-TERM OPEN-LABEL EXTENSION STUDY OF LERSIVIRINE FOR THE TREATMENT OF HIV-1 INFECTION - ND
• Scientific title: A LONG-TERM OPEN-LABEL EXTENSION STUDY OF LERSIVIRINE FOR THE TREATMENT OF HIV-1 INFECTION - ND
• Date of first enrolment: 05/02/2011
• Target sample size: 160
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-020860-39
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: no Open: no Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Italy, Portugal, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study. 2. Completion of 96 weeks of treatment with lersivirine (or comparator where required by local regulation) in one of the parent protocols. 3. HIV-1 RNA level <50 copies/mL at Week 84 of the parent protocol(if the HIV-1 RNA level is =50 copies/mL at Week 84, a second HIV-1 RNA level must be performed and confirmed to be <50 copies/mL prior to the Week 96 visit of the parent protocol). 4. Considered by the investigator to be an appropriate candidate for continued treatment with lersivirine (or comparator, where required by local regulation) plus the background therapy defined in the parent protocol. 5. Negative urine pregnancy test for Women of Child Bearing Potential (WOCBP) at the Day 1 visit, prior to receiving study medication. 6. Use of effective double barrier contraception for WOCBP for the duration of the study and for 28 days after leaving the study. For WOCBP treated with efavirenz, this period should be for the duration of the study and for 12 weeks after leaving the study. Use of effective barrier contraception for males for the duration of the study. 7. Willing and able to comply with scheduled visits,treatment plan, laboratory tests, and other study procedures.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Presence of any Grade 4 Division of AIDS (DAIDS) toxicity (except for lipids and asymptomatic glucose elevations and those discussed and agreed by the investigator and the Sponsor’s Medical Monitor prior to enrollment). 2. Use of prohibited concomitant medications, Concomitant Medications. 3. Concurrent treatment with another investigational product or in another clinical trial, except the lersivirine parent protocols. 4. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and/or in the judgment of the investigator, would make the subject inappropriate for entry into this study.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Treatment of HIV-1 infection in combination with other agents in antiretroviral treatment naive and antiretroviral treatment-experienced subjects.
MedDRA version: 9.1 Level: LLT Classification code 10020192

Intervention(s)

Product Name: Lersivirine
Product Code: UK-453,061
Pharmaceutical Form: Tablet
CAS Number: 473921-12-9
Current Sponsor code: UK-453,061
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-

Pharmaceutical Form: Tablet
INN or Proposed INN: Efavirenz
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 600-

Pharmaceutical Form: Tablet
INN or Proposed INN: Efavirenz
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Primary end point(s): 1. Safety and tolerability of lersivirine as measured by adverse event reports and safety laboratory tests. 2. The percentage of subjects with HIV-1 RNA level <50 copies/mL at 48 weeks (ie, 144 weeks from Day 1 of the parent protocol).

Main Objective: To assess the long-term safety and efficacy of lersivirine in subjects who have completed 96 weeks of treatment with lersivirine in the parent protocols.

Secondary Objective: None

Secondary ID(s)

2010-020860-39-GB

A5271037