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

NCT00824369 | Terminated Phase 2 Results

• 1 other identifier: A5271038
• Study Type: interventional
• Target: 52
• Locations: 12 countries
• Sites: 27

Brief 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.

Conditions

HIV-1

Keywords

HIV-1; Rollover; Safety.; HIV Infections; treatment experienced

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

  Baseline, Month 6, Month 12 and Last visit

• 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

  Baseline, Month 6, Month 12 and Last visit

• Absolute Cluster of Differentiation 4+ (CD4+) Cell Count (Cells/uL) at Baseline, Month 6 and Month 12

  Baseline, Month 6 and Month 12

• CD4+ Cell Count (Percentage) at Baseline, Month 6 and Month 12

  Baseline, Month 6 and Month 12

Study Arms (1)

Anti-retroviral therapy

NO INTERVENTION

Anti-retroviral therapy

Drug: No drug will be administered

Interventions

No drug will be administered DRUG

No drug will be administered.

Anti-retroviral therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Concurrent treatment in another clinical trial.
• Unwilling or unable to be followed for 12 months

Sponsors & Collaborators

• Pfizer: lead
• ViiV Healthcare: collaborator

Study Sites (27)

Pfizer Investigational Site

Sacramento, California, 95814, United States

Location

Pfizer Investigational Site

Sacramento, California, 95817, United States

Location

Pfizer Investigational Site

Miami, Florida, 33137, United States

Location

Pfizer Investigational Site

Atlanta, Georgia, 30308, United States

Location

Pfizer Investigational Site

Cincinnati, Ohio, 45267, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75235, United States

Location

Pfizer Investigational Site

Buenos Aires, C1405BCH, Argentina

Location

Pfizer Investigational Site

Curitiba, Paraná, 80240-280, Brazil

Location

Pfizer Investigational Site

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

Location

Pfizer Investigational Site

Campinas, São Paulo, 13015-080, Brazil

Location

Pfizer Investigational Site

São Paulo, São Paulo, 04121-000, Brazil

Location

Pfizer Investigational Site

Milan, 20127, Italy

Location

Pfizer Investigational Site

Kota Bharu, Kelantan, 15586, Malaysia

Location

Pfizer Investigational Site

Warsaw, 01-201, Poland

Location

Pfizer Investigational Site

Lisbon, 1349-019, Portugal

Location

Pfizer Investigational Site

Porto, 4200-319, Portugal

Location

Pfizer Investigational Site

Ponce, 00717-1563, Puerto Rico

Location

Pfizer Investigational Site

Santurce, 00909, Puerto Rico

Location

Pfizer Investigational Site

Dundee, KwaZulu-Natal, 3000, South Africa

Location

Pfizer Investigational Site

Cape Town, Western Cape, 7925, South Africa

Location

Pfizer Investigational Site

Lugano, 6903, Switzerland

Location

Pfizer Investigational Site

Sankt Gallen, 9007, Switzerland

Location

Pfizer Investigational Site

Donetsk, 83045, Ukraine

Location

Pfizer Investigational Site

Edinburgh, EH3 9HA, United Kingdom

Location

Pfizer Investigational Site

Edinburgh, EH4 2XU, United Kingdom

Location

Pfizer Investigational Site

London, SW10 9NH, United Kingdom

Location

Pfizer Investigational Site

Manchester, M8 5RB, United Kingdom

Location

Related Links

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

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

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
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2009
• First Posted: January 16, 2009
• Study Start: July 1, 2009
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: August 4, 2014
• Results First Posted: August 4, 2014

Record last verified: 2014-07

Locations

MY (1); CH (2); AR (1); BR (4); ZA (2); PT (2); PL (1); UA (1); GB (4); IT (1); PR (2); US (6)