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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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HIV-1

Intervention / Treatment
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* Drug: No drug will be administered


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Anti-retroviral therapy<br>Anti-retroviral therapy | Drug: No drug will be administered<br>* No drug will be administered.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV-1, Rollover, Safety., HIV Infections, treatment experienced