NCT01254656

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 Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2011

Geographic Reach
9 countries

23 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 6, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 9, 2014

Completed
Last Updated

June 9, 2014

Status Verified

January 1, 2014

Enrollment Period

2.2 years

First QC Date

December 3, 2010

Results QC Date

January 21, 2014

Last Update Submit

May 27, 2014

Conditions

HIV-1

Outcome Measures

Primary Outcomes (1)

  • 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.

    144 Weeks from Day 1 of the parent protocol

Secondary Outcomes (6)

  • Number of Participants With Plasma HIV-1 RNA Level <50 Copies/mL up to Week 208

    Up to Week 208

  • Change From Baseline in CD4+ Lymphocyte Counts (Absolute) at 144 Weeks From Day 1 of the Parent Protocol

    144 Weeks from Day 1 of the parent protocol

  • Change From Baseline in CD4+ Lymphocyte Counts (Percentage) at 144 Weeks From Day 1 of the Parent Protocol

    144 Weeks from Day 1 of the parent protocol

  • Change From Baseline in CD4+ Lymphocyte Counts (Absolute) at 192 Weeks From Day 1 of the Parent Protocol

    192 Weeks from Day 1 of the parent protocol

  • Change From Baseline in CD4+ Lymphocyte Counts (Percentage) at 192 Weeks From Day 1 of the Parent Protocol

    192 Weeks from Day 1 of the parent protocol

  • +1 more secondary outcomes

Study Arms (6)

LRV 500mg

EXPERIMENTAL
Drug: lersivirine

LRV 750mg +TVD

EXPERIMENTAL
Drug: lersivirine

EFV

ACTIVE COMPARATOR
Drug: efavirenz

LRV 750mg+ DRV/r + OBT

EXPERIMENTAL
Drug: lersivirine

LRV 1000mg +DRV/r + OBT

EXPERIMENTAL
Drug: lersivirine

ETR

ACTIVE COMPARATOR
Drug: etravirine

Interventions

lersivirineDRUG

Lersivirine 500 mg tablets PO taken once daily + tenofovir DF 300 mg/emtricitabine 200 mg tablets PO once daily

LRV 500mg
efavirenzDRUG

Efavirenz 600 mg tablets PO taken once daily + tenofovir DF 300 mg/emtricitabine 200 mg tablets PO once daily

EFV
etravirineDRUG

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

ETR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Pfizer Investigational Site

Darlinghurst, New South Wales, 2010, Australia

Location

Pfizer Investigational Site

Melbourne, Victoria, 3004, Australia

Location

Pfizer Investigational Site

Nova Iguaçu, Rio de Janeiro, 26030-381, Brazil

Location

Pfizer Investigational Site

Toronto, Ontario, M5G 1K2, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, H2L 4P9, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, H2L 5B1, Canada

Location

Pfizer Investigational Site

Milan, 20127, Italy

Location

Pfizer Investigational Site

Torino, 10149, Italy

Location

Pfizer Investigational Site

Mexico City, Mexico City, 14050, Mexico

Location

Pfizer Investigational Site

Bydgoszcz, 85-030, Poland

Location

Pfizer Investigational Site

Warsaw, 01-201, Poland

Location

Pfizer Investigational Site

Johannesburg, Gauteng, 2193, South Africa

Location

Pfizer Investigational Site

Pretoria, Gauteng, 0083, South Africa

Location

Pfizer Investigational Site

Soweto, Gauteng, 2013, South Africa

Location

Pfizer Investigational Site

Durban, KwaZulu-Natal, 4001, South Africa

Location

Pfizer Investigational Site

Cape Town, Western Cape, 7925, South Africa

Location

Pfizer Investigational Site

Pretoria, 0083, South Africa

Location

Pfizer Investigational Site

Lugano, 6903, Switzerland

Location

Pfizer Investigational Site

Sankt Gallen, 9007, Switzerland

Location

Pfizer Investigational Site

Zurich, 8091, Switzerland

Location

Pfizer Investigational Site

Brighton, East Sussex, BN2 1ES, United Kingdom

Location

Pfizer Investigational Site

London, NW3 2QG, United Kingdom

Location

Pfizer Investigational Site

London, SW10 9NH, United Kingdom

Location

Related Links

MeSH Terms

Interventions

UK 453,061efavirenzetravirine

Limitations and Caveats

The study was terminated on 29 Jan 13 due to termination of lersivirine development program. All participants were enrolled from study A5271015 except one from A5271022. Above summarized outcome measures included participants enrolled from A5271015.

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2010

First Posted

December 6, 2010

Study Start

February 1, 2011

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

June 9, 2014

Results First Posted

June 9, 2014

Record last verified: 2014-01

Locations

CA(3)BR(1)GB(3)AU(2)CH(3)PL(2)IT(2)ME(1)ZA(6)