A Study of Fuzeon (Enfuvirtide) With an Integrase Inhibitor Plus Optimized Background in Treatment-Experienced HIV-1 Infected Patients

Number of Patients in Phase I of the Study With a Confirmed HIV-1 RNA Viral Load ≤ 50 Copies/mL

Time frame · Between Week I-4 and Week I-12 of Phase I of the study

Virologic responders were defined as patients who had an initial HIV-1 RNA assessment \<= 50 copies/mL during Phase I at any visit between Week I-4 and Week I-12 and a confirmatory viral load assessment ≤ 50 copies/mL at the next visit (Week I-8 to Week II-16)

Number of Patients in Phase II of the Study With HIV-1 RNA ≤ 50 Copies/mL at Week II-16

Time frame · Week II-16

Virologic Response Over Time in Phase I of the Study

Time frame · Weeks 4, 8 & 12

The number of intent-to-treat (ITT) participants with HIV-1 RNA \<= 50 copies/mL and HIV-1 RNA \< 400 copies/mL by study week are summarized below.

HIV-1 RNA Viral Load Change From Baseline in Phase I of the Study

Time frame · Baseline and Weeks 4, 8, 12 & LOCF

Change from baseline in HIV-1 RNA (log10 copies/mL) at study Weeks I-4, 8, 12 \& LOCF for ITT patients in Phase I of the study

Virologic Response Over Time in Phase II of the Study

Time frame · Weeks II-4, 8, 12 & 16

The number of intent-to-treat (ITT) participants with HIV-1 RNA \<= 50 copies/mL and HIV-1 RNA \< 400 copies/mL by study week.

CD4+ Lymphocyte Count Change From Baseline

Time frame · Phase I Baseline and Phase II Weeks II-1, 12, 16, and LOCF

Change from study Phase I baseline in CD4+ lymphocyte count at Phase II study Weeks II - 1, 12, 16, and LOCF by treatment arm. Change from study Phase II baseline in CD4+ lymphocyte count at Phase II study weeks II - 12 and 16.

Percentage of Patients With Ongoing Injection Site Reactions (ISRs)

Time frame · Phase I and II