NCT00440947

See Detailed Description

Completed Phase 3 Results posted Last updated 15 March 2012

What this trial tests

Phase 3 trial testing Abacavir (ABC)/lamivudine (3TC) + atazanavir (ATV) + ritonavir (/r) in Infection, Human Immunodeficiency Virus I in 515 participants. Completed in 1 July 2010.

Timeline

1 March 2007

Primary endpoint
1 July 2010

1 July 2010

Quick facts

Lead sponsor	ViiV Healthcare
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	515
Start date	1 March 2007
Primary completion	1 July 2010
Estimated completion	1 July 2010
Sites	72 locations across United States, Canada, Puerto Rico

Drugs / interventions tested

• Abacavir (ABC)/lamivudine (3TC) + atazanavir (ATV) + ritonavir (/r) — full drug profile →
• Abacavir (ABC)/lamivudine (3TC) + atazanavir (ATV) — full drug profile →

Conditions studied

• Infection, Human Immunodeficiency Virus I — all drugs for Infection, Human Immunodeficiency Virus I →
• HIV Infection — all drugs for HIV Infection →

Sponsor

ViiV Healthcare — full company profile →

Who can join

18 and older, any sex, with Infection, Human Immunodeficiency Virus I or HIV Infection. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 Copies (c) /Milliliter (ml) at the Week 84 Visit
  Time frame: Week 84
  The percentage of PAR with HIV-1 RNA virus \<50 c/ml determined from a blood sample drawn at Week 84 was tabulated by treatment arm with stratification by baseline HIV-1 RNA (\<100,000 c/ml and \>=100,000 c/ml). Per TLOVR algorithm, responders were PAR with confirmed viral load \<50 c/ml who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA \<50

Sponsor's own description

This study was designed to test the efficacy, safety, tolerability and durability of the antiviral response between atazanavir (ATV) + ritonavir (/r) + abacavir/lamivudine(ABC/3TC) Fixed dose combination (FDC) each administered once daily (QD) for 36 weeks followed by randomization to either a simplification regimen of ATV or continuation of ATV +/r for an additional 48 weeks, each in combination with ABC/3TC in antiretroviral (ART)-naive, HIV-1 infected, HLA-B\*5701 negative subjects.

All subjects who complete the 84-week study will be eligible to enter the treatment extension phase and continue for an additional 60 weeks. The purpose of this extension is to obtain longer term treatment data in subjects who have completed the 84-week study.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Similar efficacy and tolerability of atazanavir compared with atazanavir/ritonavir, each with abacavir/lamivudine after initial suppression with abacavir/lamivudine plus ritonavir-boosted atazanavir in HIV-infected patients.
   Squires KE, Young B, Dejesus E, Bellos N, et al · · 2010 · cited 48× · PMID 20613461 · DOI 10.1097/qad.0b013e32833bee1b
2. ARIES 144 week results: durable virologic suppression in HIV-infected patients simplified to unboosted atazanavir/abacavir/lamivudine.
   Squires KE, Young B, DeJesus E, Bellos N, et al · · 2012 · cited 20× · PMID 23134624 · DOI 10.1310/hct1305-233
3. Safety and efficacy of a 36-week induction regimen of abacavir/lamivudine and ritonavir-boosted atazanavir in HIV-infected patients.
   Squires KE, Young B, DeJesus E, Bellos N, et al · · 2010 · cited 18× · PMID 20542844 · DOI 10.1310/hct1102-69
4. Inflammatory biomarker changes and their correlation with Framingham cardiovascular risk and lipid changes in antiretroviral-naive HIV-infected patients treated for 144 weeks with abacavir/lamivudine/atazanavir with or without ritonavir in ARIES.
   Young B, Squires KE, Ross LL, Santiago L, et al · · 2013 · cited 16× · PMID 23039030 · DOI 10.1089/aid.2012.0278
5. Protease Inhibitors and Renal Function in Patients with HIV Infection: a Systematic Review.
   Bagnis CI, Stellbrink HJ. · · 2015 · cited 15× · PMID 25567681 · DOI 10.1007/s40121-014-0056-4
6. Atazanavir and Cardiovascular Risk Among Human Immunodeficiency Virus-Infected Patients: A Systematic Review.
   Chow D, Shikuma C, Ritchings C, Guo M, et al · · 2016 · cited 11× · PMID 27677263 · DOI 10.1007/s40121-016-0132-z
7. Response by gender of HIV-1-infected subjects treated with abacavir/lamivudine plus atazanavir, with or without ritonavir, for 144 weeks.
   Squires KE, Young B, Santiago L, Dretler RH, et al · · 2017 · cited 5× · PMID 28424561 · DOI 10.2147/hiv.s108756
8. HIV-1 transmission patterns in antiretroviral therapy-naïve, HIV-infected North Americans based on phylogenetic analysis by population level and ultra-deep DNA sequencing.
   Ross LL, Horton J, Hasan S, Brown JR, et al · · 2014 · cited 3× · PMID 24586911 · DOI 10.1371/journal.pone.0089611