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

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.

Time frame: 144 Weeks from Day 1 of the parent protocol

Population: All participants enrolled in this protocol constituted the analysis population associated with each of the parent protocols and all available data were used for efficacy analyses.

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)

Time frame: 144 Weeks from Day 1 of the parent protocol

Population: All participants enrolled in this protocol constituted the analysis population associated with each of the parent protocols and all available data were used for efficacy analyses. Last observation carried forward (LOCF) was used to impute missing values.

Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 192 weeks from Day 1 of the parent protocol.

Time frame: 192 Weeks from Day 1 of the parent protocol

Population: Analyses included all enrolled participants. Week 192 data are presented, as Week 208 had few participants. For participants who discontinued prematurely, LOCF was used to impute values for post discontinuation visits. Participants who discontinued due to termination of the program were not included in the analysis for the post termination visits.

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)

Time frame: 144 Weeks from Day 1 of the parent protocol

Population: All participants enrolled in this protocol constituted the analysis population associated with each of the parent protocols and all available data were used for efficacy analyses. LOCF was used to impute missing values.

Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 192 weeks from Day 1 of the parent protocol.

Time frame: 192 Weeks from Day 1 of the parent protocol

Population: Analyses included all enrolled participants. Week 192 data are presented as Week 208 had few participants. For participants who discontinued prematurely, LOCF was used to impute values for post discontinuation visits. Participants who discontinued due to termination of the program were not included in the analysis for the post termination visits.

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.

Time frame: Up to Week 208

Population: Analyses included all enrolled participants. Last visit used the last available visit of each participant. Discontinued from study, lost to follow-up, or missing HIV-1 RNA level data at last visit were considered to have HIV-1 RNA levels \>=50 copies/mL. Participants discontinued due to program termination were not considered as discontinuations.

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.

Time frame: Week 96 through study termination

Population: The virology analysis set included only evaluable participants i.e. those having samples with valid genotypic or phenotypic susceptibility testing results and HIV-1 RNA \>500 copies/mL. However, samples with observed emergence of resistance-associated mutations and HIV-1 RNA level ≤500 copies/mL or missing HIV-1 RNA level, were also noted.