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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01254656




Registration number
NCT01254656
Ethics application status
Date submitted
3/12/2010
Date registered
6/12/2010
Date last updated
9/06/2014

Titles & IDs
Public title
A Long Term Safety Study Of Lersivirine For The Treatment Of HIV-1 Infection In Subjects Who Have Completed Treatment With Lersivirine In Studies A5271015 And A5271022
Scientific title
A Long Term Open-Label Extension Study Of Lersivirine For The Treatment Of HIV-1 Infection
Secondary ID [1] 0 0
A5271037
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV-1 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - lersivirine
Treatment: Drugs - lersivirine
Treatment: Drugs - efavirenz
Treatment: Drugs - lersivirine
Treatment: Drugs - lersivirine
Treatment: Drugs - etravirine

Experimental: LRV 500mg -

Experimental: LRV 750mg +TVD -

Active Comparator: EFV -

Experimental: LRV 750mg+ DRV/r + OBT -

Experimental: LRV 1000mg +DRV/r + OBT -

Active Comparator: ETR -


Treatment: Drugs: lersivirine
Lersivirine 500 mg tablets PO taken once daily + tenofovir DF 300 mg/emtricitabine 200 mg tablets PO once daily

Treatment: Drugs: lersivirine
Lersivirine 750 mg tablets PO taken once daily + tenofovir DF 300 mg/emtricitabine 200 mg tablets PO once daily

Treatment: Drugs: efavirenz
Efavirenz 600 mg tablets PO taken once daily + tenofovir DF 300 mg/emtricitabine 200 mg tablets PO once daily

Treatment: Drugs: lersivirine
Lersivirine 750 mg tablets PO taken once daily + darunavir 600 mg tablets/ritonavir 100 mg tablets or capsules PO taken twice daily + 1 optimized NRTI

Treatment: Drugs: lersivirine
Lersivirine 1000 mg PO tablets + darunavir 600 mg tablets/ritonavir 100 mg tablets or capsules PO taken twice daily + 1 optimized NRTI

Treatment: Drugs: etravirine
Etravirine 200 mg PO tablets + darunavir 600 mg tablets/ritonavir 100 mg tablets or capsules taken twice daily + 1 optimized NRTI

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Plasma Human Immunodeficiency Virus - 1 (HIV-1) Ribonucleic Acid (RNA) Level <50 Copies/mL at 144 Weeks From Day 1 of the Parent Protocol - Number of participants with HIV-1 RNA level <50 copies/mL plasma was summarized at 48 weeks i.e. 144 weeks from Day 1 of the parent protocol. Roche Amplicor HIV-1 Monitor assay was used to measure the HIV-1 RNA level.
Timepoint [1] 0 0
144 Weeks from Day 1 of the parent protocol
Secondary outcome [1] 0 0
Number of Participants With Plasma HIV-1 RNA Level <50 Copies/mL up to Week 208 - Number of participants with HIV-1 RNA level <50 copies/mL plasma was summarized at last visit. Abbott RealTime HIV-1 assay was used to measure the HIV-1 RNA level.
Timepoint [1] 0 0
Up to Week 208
Secondary outcome [2] 0 0
Change From Baseline in CD4+ Lymphocyte Counts (Absolute) at 144 Weeks From Day 1 of the Parent Protocol - Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 48 weeks (ie, 144 weeks from Day 1 of the parent protocol)
Timepoint [2] 0 0
144 Weeks from Day 1 of the parent protocol
Secondary outcome [3] 0 0
Change From Baseline in CD4+ Lymphocyte Counts (Percentage) at 144 Weeks From Day 1 of the Parent Protocol - Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 48 weeks (ie, 144 weeks from Day 1 of the parent protocol)
Timepoint [3] 0 0
144 Weeks from Day 1 of the parent protocol
Secondary outcome [4] 0 0
Change From Baseline in CD4+ Lymphocyte Counts (Absolute) at 192 Weeks From Day 1 of the Parent Protocol - Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 192 weeks from Day 1 of the parent protocol.
Timepoint [4] 0 0
192 Weeks from Day 1 of the parent protocol
Secondary outcome [5] 0 0
Change From Baseline in CD4+ Lymphocyte Counts (Percentage) at 192 Weeks From Day 1 of the Parent Protocol - Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 192 weeks from Day 1 of the parent protocol.
Timepoint [5] 0 0
192 Weeks from Day 1 of the parent protocol
Secondary outcome [6] 0 0
Virology Analysis Participant Accountability From Week 96 Through Study Termination - Virology analysis included virus susceptibility (phenotype and genotype)to a standard panel of approved antiretrovirals as determined by the Monogram Biosciences PhenoSense GT assay. Below analysis table included the following parameters: 1. "protocol-defined treatment failure" was defined as an increase in HIV-1 RNA to detectable levels (=50 copies/mL) on 2 consecutive measurements, the second measurement taken no more than 14 days after the first measurement); 2. "Treatment failure": treatment failure (both virologic and non-virologic) was defined as a subject who met the protocol-defined treatment failure criterion or discontinued from the study; 3. "NRTI or NNRTI resistance mutations": nucleoside reverse transcriptase inhibitor or lersivirine-associated resistance-associated mutations (RAM) based on the International AIDS Society-USA (IAS-USA) RAM guidelines; 4. 'with result' meant an analyzed sample returned genotypic result or phenotypic result or both.
Timepoint [6] 0 0
Week 96 through study termination

Eligibility
Key inclusion criteria
- Patients must complete of 96 weeks of treatment with lersivirine (or comparator where
required by local regulation) in one of the parent protocols (A5271015 or A5271022).

- Patients must have had a viral load less than 50 copies/mL at Week 84 of the parent
protocol.

- For women who can have children, a negative urine pregnancy test at the Day 1 visit.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients with any Grade 4 Division of AIDS toxicity (except for lipids and
asymptomatic glucose elevations will not be included in this trial.

- Patients being treated with another investigational product or in another clinical
trial, except the lersivirine parent protocols will not be included in this trial.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Darlinghurst
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
RJ
Country [2] 0 0
Canada
State/province [2] 0 0
Ontario
Country [3] 0 0
Canada
State/province [3] 0 0
Quebec
Country [4] 0 0
Italy
State/province [4] 0 0
Milano
Country [5] 0 0
Italy
State/province [5] 0 0
Torino
Country [6] 0 0
Mexico
State/province [6] 0 0
Distrito Federal
Country [7] 0 0
Poland
State/province [7] 0 0
Bydgoszcz
Country [8] 0 0
Poland
State/province [8] 0 0
Warszawa
Country [9] 0 0
South Africa
State/province [9] 0 0
Gauteng
Country [10] 0 0
South Africa
State/province [10] 0 0
Kwazulu-Natal
Country [11] 0 0
South Africa
State/province [11] 0 0
Western Cape
Country [12] 0 0
South Africa
State/province [12] 0 0
Pretoria
Country [13] 0 0
Switzerland
State/province [13] 0 0
Lugano
Country [14] 0 0
Switzerland
State/province [14] 0 0
St. Gallen
Country [15] 0 0
Switzerland
State/province [15] 0 0
Zuerich
Country [16] 0 0
United Kingdom
State/province [16] 0 0
East Sussex
Country [17] 0 0
United Kingdom
State/province [17] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
ViiV Healthcare
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is a study to assess long-term safety and efficacy of lersivirine in patients who have
completed 96 weeks of treatment with lersivirine in studies A5271015 and A5271022.
Trial website
https://clinicaltrials.gov/show/NCT01254656
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01254656