Switching Undetectables to Selzentry

The objective of the study is to determine if regimen tolerability/toxicity can be maintained
or improved while maintaining virologic suppression following a switch to once-daily
Selzentry®.

The study duration is 48 weeks. Patients must have an HIV-1 RNA <100 copies/mL for ≥3 months
on their first HIV treatment regimen. Prior regimen modifications for reasons other than
virologic failure are acceptable if any previously achieved virologic suppression has been
maintained. A Trofile® DNA will be used to document exclusive CCR5 tropism. Patients with
history of dual/mixed or CXCR4-tropic HIV-1 are excluded from participation. Patients with
prior exposure to Selzentry® are also excluded. Patients that qualify for participation will
discontinue the PI, NNRTI, or Integrase inhibitor portion of their regimen and begin
Selzentry® 600mg QD. Patients will continue the two (2) NRTIs from the previous treatment
regimen.

The primary endpoints is: the percentage of HIV positive patients with undetectable viral
load (HIV-1 RNA <100 copies/mL) at Week 24.

Secondary endpoints are: the safety and tolerability of once-daily Selzentry® through Weeks
24 and 48(as measured by clinical and laboratory adverse events and regimen satisfaction
questionnaire), the percentage of HIV positive patients with undetectable viral load (HIV-1
RNA < 100 copies/mL) at Week 48, the change from baseline in CD4+ T-cell counts at Weeks 24
and 48, the change from baseline in inflammatory markers (C-reactive protein) at Weeks 24 and
48, and assessment of resistance-associated mutations or viral tropism changes from baseline,
if any, emerging at virologic failure.

Inclusion Criteria:

- 18 years of age or older

- Are capable of understanding and have signed an informed consent

- Have documented HIV-1 infection by confirmatory laboratory

- Have no acquired immunodeficiency syndrome (AIDS)-defining events in the 3 months
before screening, other than cutaneous Kaposi's sarcoma or wasting syndrome due to HIV

- Are able and willing to comply with all protocol requirements and procedures

- Have HIV-1 RNA <100 copies/mL and documented CCR5 tropic virus

- Are receiving their first highly active antiretroviral regimen for at least 12 weeks
before screening and are willing to continue that regimen until the baseline visit
(previous regimen modifications for reasons other than virologic failure are
acceptable if any previously achieved virologic suppression has been maintained)

- Antiretroviral regimen is composed of one NNRTI, one PI (including boosted PIs), or
one integrase inhibitor AND two (2) NRTIs

Exclusion Criteria:

- Any history of virologic failure or resistance associated mutations on prior
resistance testing

- Any history of dual/mixed- or CXCR4-tropic HIV-1

- Any history of an active AIDS-defining illness per Category C conditions according to
the Center for Disease Control (CDC) Classification System for HIV Infection, with the
following exceptions: cutaneous Kaposi's sarcoma and wasting syndrome due to HIV

- Any significant diseases (other than HIV-1 infection) or clinically significant
findings, including psychiatric and behavioral problems, determined from screening,
medical history and/or physical examination that, in the investigator's opinion, would
preclude the patient from participating in this study

- Any significant acute illness within 1 week before the initial administration of study
drug

- Any active infection secondary to HIV requiring acute therapy; however, patients that
require maintenance therapy (i.e. secondary prophylaxis for opportunistic infections)
will be eligible for the study

- HCV infection requiring treatment during the study period