A Rollover Study For Subjects Discontinuing From UK-453,061 Studies For The Treatment Of HIV-1

HIV-1 Clinical Trial

Official title:

A Phase 2b Open-Label Rollover Study For Subjects Discontinuing From UK-453,061 Studies For The Treatment Of HIV-1 Infected Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00824369
• Other study ID #: A5271038
• Status: Terminated
• Phase: Phase 2
• First received: January 15, 2009
• Last updated: July 31, 2014
• Start date: July 2009
• Est. completion date: July 2013

Study information

• Verified date: July 2014
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of the protocol is to assess long-term safety and tolerability of subjects who discontinue for any reason from UK-453,061 qualifying studies.

Description:

To assess long term safety and tolerability of subjects who discontinue for any reason from UK-453,061 studies. The study will also assess efficacy of the subsequent regimens in these patients. The trial was terminated prematurely on January 29, 2013, due to the decision of the sponsor to discontinue development of lersivirine. The decision to terminate the trial was not based on any safety or efficacy concerns.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 52
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Previous participation in a qualifying study.

• Male or female at least 18 years of age available for a follow-up period of at least 96 weeks.

Exclusion Criteria:

• Concurrent treatment in another clinical trial.

• Unwilling or unable to be followed for 12 months

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• HIV-1

Intervention

Drug:
• No drug will be administered
No drug will be administered.

Locations

Country	Name	City	State
Argentina	Pfizer Investigational Site	Buenos Aires
Brazil	Pfizer Investigational Site	Campinas	SP
Brazil	Pfizer Investigational Site	Curitiba	PR
Brazil	Pfizer Investigational Site	Nova Iguacu	RJ
Brazil	Pfizer Investigational Site	Sao Paulo	SP
Italy	Pfizer Investigational Site	Milano
Malaysia	Pfizer Investigational Site	Kota Bharu	Kelantan
Poland	Pfizer Investigational Site	Warszawa
Portugal	Pfizer Investigational Site	Lisboa
Portugal	Pfizer Investigational Site	Porto
Puerto Rico	Pfizer Investigational Site	Ponce
Puerto Rico	Pfizer Investigational Site	Santurce
South Africa	Pfizer Investigational Site	Cape Town	Western Cape
South Africa	Pfizer Investigational Site	Dundee	Kwazulu-Natal
Switzerland	Pfizer Investigational Site	Lugano
Switzerland	Pfizer Investigational Site	St. Gallen
Ukraine	Pfizer Investigational Site	Donetsk
United Kingdom	Pfizer Investigational Site	Edinburgh
United Kingdom	Pfizer Investigational Site	Edinburgh
United Kingdom	Pfizer Investigational Site	London
United Kingdom	Pfizer Investigational Site	Manchester
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Sacramento	California
United States	Pfizer Investigational Site	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	ViiV Healthcare

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Italy,  Malaysia,  Poland,  Portugal,  Puerto Rico,  South Africa,  Switzerland,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events and Participants Who Discontinued Due to Adverse Events	The numbers of participants with treatment emergent adverse events, serious adverse events or discontinuation due to adverse events was reported.	End of Study visit or the Early Termination visit	Yes
Secondary	Number of Participants With Human Immunodeficiency Virus - 1 (HIV 1) Ribonucleic Acid (RNA) Level <50 Copies/mL at Baseline, Month 6, Month 12 and Last Visit	Number of participants with HIV-1 RNA level <50 copies/mL plasma was noted at baseline, month 6, month 12 and last visit.	Baseline, Month 6, Month 12 and Last visit	No
Secondary	Number of Participants With HIV 1 RNA Level <50 Copies/mL or Below the Lower Limit of Quantification (LLOQ) of the Assay at Baseline, Month 6, Month 12 and Last Visit	Number of participants with HIV-1 RNA level <50 copies/mL plasma or below the lower limit of quantification (LLOQ) of the Assay were noted at Baseline, Month 6, Month 12 and Last visit. The lower limit of quantification (LLOQ) of the HIV 1 RNA assays ranged from 20 to 70 copies/mL as the assay was performed by local labs.	Baseline, Month 6, Month 12 and Last visit	No
Secondary	Absolute Cluster of Differentiation 4+ (CD4+) Cell Count (Cells/uL) at Baseline, Month 6 and Month 12	Participant's immunological status assessed by CD4+ lymphocyte count.	Baseline, Month 6 and Month 12	No
Secondary	CD4+ Cell Count (Percentage) at Baseline, Month 6 and Month 12	Participant's immunological status assessed by CD4+ lymphocyte count.	Baseline, Month 6 and Month 12	No

External Links

•   To obtain contact information for a study center near you, click here.