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

Number of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL

Time frame · Week 24

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.

Percentage of Participants With HIV-1 RNA Viral Load <50 Copies/mL

Time frame · Week 24

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.

Number of Participants With HIV-1 RNA Viral Load <50 Copies/mL

Time frame · Week 4 and 12

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.

Percentage of Participants With HIV-1 RNA Viral Load <50 Copies/mL

Time frame · Week 4 and 12

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.

Number of Participants With HIV-1 RNA Viral Load <400 Copies/mL

Time frame · Weeks 4, 12, and 24

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.

Percentage of Participants With HIV-1 RNA Viral Load <400 Copies/mL

Time frame · Weeks 4, 12, and 24

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.

Change From Baseline in Log 10 Plasma HIV-1 RNA Viral Load

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

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).

Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE)

Time frame · Up to Week 28

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.

Change From Baseline in CD4+ Lymphocyte Count

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

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).

Number of Participants Meeting Virologic Failure Criteria

Time frame · Weeks 12 and 24

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.

Percentage of Participants Meeting Virologic Failure Criteria

Time frame · Weeks 12 and 24

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.

Number of Participants Adhering to Enfuvirtide (ENF)

Time frame · Weeks 4, 12, and 24

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.