BLQ Study: A Study of a Protease Inhibitor With Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With HIV-1.

Blood samples for HIV-1 RNA viral load measurement were collected at the Week 24 clinic visit. The number of participants with HIV-1 RNA viral load results \<50 copies/mL is reported.

Time frame: Week 24

Population: Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.

Blood samples for HIV-1 RNA viral load measurement were collected at the Week 24 clinic visit. The percentage of participants with HIV-1 RNA results \<50 copies/mL is reported.

Time frame: Week 24

Population: Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.

Summary statistics for change from baseline in CD4+ lymphocyte count were presented . Change from baseline in CD4+ lymphocyte count was derived as follows: Change from baseline = (CD4+ count at Week X) - (CD4+ count at baseline).

Time frame: Baseline (Day 1), Weeks 4, 12, and 24

Population: Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment. Maximum number of participants available at the particular time point were analysed and reported.

Summary statistics for change from baseline in plasma HIV-1 RNA count were presented. Change from baseline in plasma HIV-1 RNA count was derived as follows: Change from baseline = (plasma HIV-1 RNA count at Week X) - (plasma HIV-1 RNA count at baseline).

Time frame: Baseline (Day 1), Weeks 4, 12, and 24

Population: Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment. Maximum number of participants available at the particular time point were analysed and reported.

Injection site reactions (ISRs) referred to any localized sign or symptom, including erythema, induration, pruritus, nodules, ecchymosis (degree of bruising/ discoloration), and pain/discomfort. Injection site reactions were monitored by trained study personnel at weeks 1, 4, 12, 16, and 24. Grades 0 through 4 are a measure of intensity, not seriousness. Thus, a grade 3 or grade 4 sign or symptom could be severe, but not necessarily serious. Only active, ongoing ISR were counted. The maximum severity grade for pain/discomfort since the last visit at any injection site was recorded whether or not the maximum severity of pain/discomfort was ongoing at the time of clinical evaluation.

Time frame: Week 24

Population: Analysis was performed on the Safety Population. The Safety Population included all the participants who received at least one dose of trial medication and had a safety follow-up. Maximum number of participants available at the particular time point were analysed and reported.

Adherence to ENF treatment regimen was calculated using the participant's response to the query on the Participant Adherence Questionnaire case report form (CRF) about injections incomplete or missed in the last 4 days preceding the study visit. The percentage adherence to the ENF regimen at each study visit is given by: % Adherence = (\[8 - the number of doses missed\] / 8) x 100. The number and percentage of participants adhering to the ENF regimen were presented by adherence category (100%, ≥95%, ≥90% and ≥85%) at Weeks 4, 12, and 24.

Time frame: Weeks 4, 12, and 24

Population: Analysis was performed on the Intent-to-treat (ITT) Population.The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment. Maximum number of participants available at the particular time point were analysed and reported.

The total number and percentage of participants who discontinued the study medication (ENF) due to clinical adverse events (including clinically significant laboratory abnormalities and AIDS Clinical Trials Group (ACTG) grade≥3 laboratory toxicities) were noted and presented.

Time frame: Up to Week 24

Population: Analysis was performed on the Safety Population. The Safety Population included all the participants who received at least one dose of trial medication and had a safety follow-up.

The participant was considered as virologic failure at Week 12 clinic visit if patient achieved HIV-RNA \<50 copies/mL at Week 4, and HIV-RNA \> 50 copies/mL at Week 12, and HIV-RNA \>50 copies/mL confirmed at 2 to 4 weeks after Week 12 or if participants failed to achieve a viral load decrease from baseline greater or equal to 0.5 log10 at Week 12 and failed to achieve a viral load decrease from baseline greater or equal to 0.5 log10 confirmed at 2 to 4 weeks after Week 12. The participant was considered as virologic failure at Week 24 clinic visit if participant achieved HIV-RNA \<50 copies/mL at week 12, and HIV-RNA \>50 copies/mL at week 24/early discontinuation, and HIV-RNA \>50 copies/mL confirmed at 2 to 4 weeks after week 24/early discontinuation or HIV-RNA \>50 copies/mL at any time up to week 24 and HIV-RNA \>50 copies/mL confirmed at 2 to 4 weeks after week 24/early discontinuation.

Time frame: Weeks 12 and 24

Population: Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.

Injection site reactions (ISRs) referred to any localized sign or symptom, including erythema, induration, pruritus, nodules, ecchymosis (degree of bruising/ discoloration), and pain/discomfort. Injection site reactions were monitored by trained study personnel at weeks 1, 4, 12, 16, and 24. Interruption of ENF for toxicity management of recurrent local grade 3 or 4 ISRs until the sign or symptom resolved to grade 2 was at the discretion of the investigator. Any individual injection site signs or symptoms meeting the criteria for a serious adverse event (SAE) had to be reported as an SAE. In the event of a serious ISR, the participant was to immediately discontinue ENF and withdraw from the study. If the participant was not already hospitalized, serious ISRs required a clinic visit within 72 hours of the event.

Time frame: Week 1 to Week 24

Population: Analysis was performed on the Safety Population. The Safety Population included all the participants who received at least one dose of trial medication and had a safety follow-up.

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAEs are defined as those events that were fatal or immediately life-threatening, and those events that resulted in hospitalization; prolonged an existing hospitalization; resulted in disability; or was a congenital anomaly.

Time frame: Up to Week 28

Population: Analysis was performed on the Safety Population. The Safety Population included all the participants who received at least one dose of trial medication and had a safety follow-up.

Blood samples for HIV-1 RNA viral load measurement were collected at the Week 4, Week 12, and Week 24 clinic visit. The number of participants with HIV-1 RNA Viral Load results \<400 copies/mL is reported.

Time frame: Weeks 4, 12, and 24

Population: Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.

Blood samples for HIV-1 RNA viral load measurement were collected at the Week 4 and Week 12 clinic visit. The number of participants with HIV-1 RNA results \<50 copies/mL is reported.

Time frame: Week 4 and 12

Population: Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.

Adherence to ENF treatment regimen was calculated using the participant's response to the query on the Participant Adherence Questionnaire case report form (CRF) about injections incomplete or missed in the last 4 days preceding the study visit. The percentage adherence to the ENF regimen at each study visit is given by: % Adherence = (\[8 - the number of doses missed\] / 8) x 100. The number and percentage of participants adhering to the ENF regimen were presented by adherence category (100%, ≥95%, ≥90% and ≥85%) at Weeks 4, 12, and 24.

Time frame: Weeks 4, 12, and 24

Population: Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment. Maximum number of participants available at the particular time point were analysed and reported.

The participant was considered as virologic failure at Week 12 clinic visit if patient achieved HIV-RNA \<50 copies/mL at Week 4, and HIV-RNA \> 50 copies/mL at Week 12, and HIV-RNA \>50 copies/mL confirmed at 2 to 4 weeks after Week 12 or if participants failed to achieve a viral load decrease from baseline greater or equal to 0.5 log10 at Week 12 and failed to achieve a viral load decrease from baseline greater or equal to 0.5 log10 confirmed at 2 to 4 weeks after Week 12. The participant was considered as virologic failure at Week 24 clinic visit if participant achieved HIV-RNA \<50 copies/mL at week 12, and HIV-RNA \>50 copies/mL at week 24/early discontinuation, and HIV-RNA \>50 copies/mL confirmed at 2 to 4 weeks after week 24/early discontinuation or HIV-RNA \>50 copies/mL at any time up to week 24 and HIV-RNA \>50 copies/mL confirmed at 2 to 4 weeks after week 24/early discontinuation.

Time frame: Weeks 12 and 24

Population: Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.

Injection site reactions (ISRs) referred to any localized sign or symptom, including erythema, induration, pruritus, nodules, ecchymosis (degree of bruising/ discoloration), and pain/discomfort. Injection site reactions were monitored by trained study personnel at weeks 1, 4, 12, 16, and 24. Interruption of ENF for toxicity management of recurrent local grade 3 or 4 ISRs until the sign or symptom resolved to grade 2 was at the discretion of the investigator. Any individual injection site signs or symptoms meeting the criteria for a serious adverse event (SAE) had to be reported as an SAE. In the event of a serious ISR, the participant was to immediately discontinue ENF and withdraw from the study. If the participant was not already hospitalized, serious ISRs required a clinic visit within 72 hours of the event.

Time frame: Week 1 to Week 24

Population: Analysis was performed on the Safety Population. The Safety Population included all the participants who received at least one dose of trial medication and had a safety follow-up.

Blood samples for HIV-1 RNA viral load measurement were collected at the Week 4, Week 12, and Week 24 clinic visit. The number of participants with HIV-1 RNA Viral Load results \<400 copies/mL is reported.

Time frame: Weeks 4, 12, and 24

Population: Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.

Blood samples for HIV-1 RNA viral load measurement were collected at the Week 4 and Week 12 clinic visit. The percentage of participants with HIV-1 RNA Viral Load results \<50 copies/mL is reported.

Time frame: Week 4 and 12

Population: Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.