A Simplification Study of Unboosted Reyataz With Epzicom (ASSURE)

Trial end date:
Target enrollment:
Participant gender:
This study is designed to compare the efficacy and safety of simplifying therapy from a regimen of atazanavir (ATV) + ritonavir (RTV) + tenofovir/emtricitabine (TDF/FTC) to a regimen of ATV + abacavir sulfate/lamivudine (ABC/3TC) without RTV in virologically suppressed, HIV-1 infected, HLA-B*5701 negative subjects for 48 weeks.
Phase 4
Accepts Healthy Volunteers?
Lead Sponsor:
ViiV Healthcare
Atazanavir Sulfate
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Inclusion Criteria:

- Subject is an adult (greater than or equal to 18 years) with documented HIV-1

- Subject is a male or female of non-childbearing potential (physiologically incapable
of becoming pregnant, is pre-menarchal or post-menopausal) or child-bearing potential
with a negative pregnancy test who agrees to avoid pregnancy by sexual abstinence or
utilization of a highly effective method of birth control throughout the study period

- Subject is receiving a once-daily regimen of ATV (300mg) + RTV (100mg) + TDF/FTC
(300mg/200mg) for at least 6 months prior to or by the first day of screening. ATV +
RTV + TDF/FTC must be the subejct's INITIAL regimen or FIRST or SECOND SWITCH regimen.
If ATV + RTV + TDF/FTC is subject's first or second switch regimen, then subject may
ONLY have received the following prior regimens: a) any currently licensed
non-nucleoside reverse transcriptase inhibitor (NNRTI) + TDF/FTC or ZDV/3TC; b)
RTV-boosted PI with TDF/FTC or ZDV/3TC; or c) an alternative regimen not listed above
after approval by Sponsor.

- Subject is virologically suppressed on ATV + RTV + TDF/FTC defined as HIV-1 RNA copies/mL at 2 consecutive timepoints, one of which is at Screening and the other at
least 28 days prior to Screening

Exclusion Criteria:

- Subject has evidence of virologic failure

- Subject has any known HIV genotyping results indicating HIV virus contains any of the
following resistance mutations in reverse transcriptase including K65R, K70E, L74V,
M184I/V or Y115F, a combination of two or more thymidine analog mutations including
M41L, D67N, K70R, K219Q or E that include changes at either L210 or T215), or 3 or
more of the following HIV-1 protease mutations associated with atazanavir resistance:
D30, V32, M36, M46, I47, G48, I50, I54, A71, G73, V77, V82, I84, N88, and L90

- Subject is HLA-B*5701 positive

- Subject has hypersensitivity to any component of the study drugs

- SUbject is pregnant or breastfeeding

- Subject is enrolled in one or more investigational drug protocols within 30 days of

- Subject has an active Center for Disease Control and Prevention (CDC) Category C
disease, except cutaneous Kaposi's sarcoma not requiring systemic therapy during the

- Subject has ongoing clinically relevant hepatitis at screening and/or positive for
Hepatitis B (+ HbsAg)

- Subject has a creatinine clearance <50 mL/min via the Cockcroft-Gault method

- Subject has a verified Grade 4 laboratory abnormality at screening unless the
Investigator can provide a compelling explanation (e.g. elevated CPK due to exercise)
for the laboratory result(s) and has the assent of the Sponsor

- Subject has any other laboratory abnormality or medical condition at screening, which,
in the opinion of the investigator, would preclude the subject's participation in the

- Subject has had an immunization within 30 days prior to first dose of investigational

- Subject has had any exposure to treatment with immunomodulating agents (such as
systemic corticosteroids, interleukins, or interferons) or receipt of an HIV-1
immunotherapeutic vaccine within 90 days prior to screening. Subjects using inhaled
corticosteroids or short-course systemic corticosteroids (less than or equal to 14
days) are eligible for enrollment.

- Subject has had treatment with radiation therapy or cytotoxic chemotherapeutic agents
within 90 days prior to screening, or has an anticipated need for these agents within
the study period

- Subject has had treatment within 30 days prior to first dose of investigational
product for or an anticipated need during the study of any medications which can have
interactions with the study medications, TDF, FTC, ABC, 3TC, ATV and/or RTV, as
described in current product labelling

- Subject has had treatment with any previous abacavir-containing regimen