Brief Summary

Combination antiretroviral therapy for the treatment of HIV has a high pill burden. Two dual-tablets, abacavir-lamivudine and tenofovir-emtricitabine, are now licensed in the United States and will be available in Australia in December 2005. Data available suggest that the potency of these tablets are similar in controlling replication of the HIV virus, but not have not been directly compared in regard to clinically significant toxicities. We therefore aim to compare the overall safety and efficacy of the two dual-tablets over a 2 year period in HIV infected adults. We hypothesise that the two dual-NRTI treatments will be similar in efficacy and safety.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

357

participants targeted

Target at P75+ for phase_4 hiv-infections

Timeline

Completed

Started Dec 2005

Typical duration for phase_4 hiv-infections

Geographic Reach

1 country

31 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.7 years study duration

First Submitted

Initial submission to the registry

September 13, 2005

Completed

6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed

2 months until next milestone

Study Start

First participant enrolled

December 1, 2005

Completed

2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed

Last Updated

May 25, 2011

Status Verified

May 1, 2011

Enrollment Period

2.7 years

First QC Date

September 13, 2005

Last Update Submit

May 24, 2011

Conditions

HIV Infections

Keywords

HIVAntiretroviral therapynucleoside analogue reverse transcriptasefixed dose combinationTreatment Experienced

Outcome Measures

Primary Outcomes (1)

virological failure defined by HIV RNA>400copies/mL plasma on 2 consecutive occasions ³4 wks apart(Roche Amplicor v1.5, LLD 50 copies/mL)
Week 48

Secondary Outcomes (2)

plasma HIV RNA<50copies/mL; time to virological failure (VF); virological resistance in those with VF; all SAEs; use of concomitant meds for toxicity; adherence; QoL; CD4+lymphocyte count; full blood count; biochemistry; lipid parameters
Week 48 and 96
glycaemic parameters; DEXA parameters; resolution of AEs; progression to AIDS; death; discontinuation of ART.
Week 48 and 96

Study Arms (2)

1

ACTIVE COMPARATOR

Abacavir 600mg/Lamivudine 300mg

Drug: Abacavir 600mg - Lamivudine 300mg

2

ACTIVE COMPARATOR

Tenofovir 300mg/emtricitabine 200mg

Drug: Emtricitabine 200mg - Tenofovir 300mg

Interventions

Emtricitabine 200mg - Tenofovir 300mgDRUG

1 tablet once daily for 96 weeks

Also known as: Truvada

Abacavir 600mg - Lamivudine 300mgDRUG

1 tablet once daily for 96 weeks

Also known as: Kivexa

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

documented HIV infection
age at least 18 years
stable (≥ to 12 weeks) ART including at least two NRTIs, currently well tolerated, with no plan to change any other component of the ART regimen at or after baseline
HIV RNA \< 50 copies/mL plasma for the preceding 12 weeks
GFR ≥ 70 mL/min/1.73m2 (estimated by the abbreviated MDRD equation23 estimated GFR = 186 x (\[SCR/88.4\]-1.154) x age-0.203 x (0.742 if female) x (1.210 if African-American)
provision of written, informed consent

You may not qualify if:

HLA-B\*5701 positive at screening OR evidence of previous ABC hypersensitivity OR clinical failure in participants taking abacavir for at least 30 days
current therapy comprising triple NRTI therapy alone
current use of ABC/3TC FDC (Kivexa) or TDF/FTC FDC (Truvada)
history of non-traumatic osteoporotic fracture
prior hypersensitivity or intolerance to ABC, 3TC, TDF or FTC
prior clinical failure to a regimen containing ABC or TDF
prior use of TDF for control of previously active hepatitis B (HBsAg+ or HBV DNA+) in patients likely to be resistant to 3TC/FTC
current therapy including unboosted atazanavir
concurrent use of aminoglycosides, IV amphotericin B, cidofovir, cisplatin, foscarnet, IV pentamidine, probenecid, adefovir or immunomodulatory agents
clinical evidence of cirrhosis (e.g. smooth liver, no features of portal hypertension)
creatinine clearance \< 50 mL/min (estimated by the Cockcroft-Gault equation)18,19
Male: (140 - age in years) x (wt in kg) = CLCr (mL/min) 0.814 x (serum creatinine in µmol/L)
Female:(140 - age in years) x (wt in kg) x 0.85 = CLCr (mL/min) 0.814 x (serum creatinine in µmol/L)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Kirby Institutelead

Study Sites (31)

Holdsworth House General Practice - Byron Bay

Byron Bay, New South Wales, 2481, Australia

Location

Lismore Sexual Health Clinic - Northen Rivers Area Health Service

Lismore, New South Wales, 2480, Australia

Location

John Hunter Hospital

Newcastle, New South Wales, 2304, Australia

Location

407 Doctors