A Study Comparing Safety Of Abacavir And Lamivudine Administered Once-Daily As A Single Tablet Versus The Same Drugs Administered Twice-Daily As Separate Tablets (ALOHA Study)

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00094367
First received: October 16, 2004
Last updated: September 29, 2010
Last verified: September 2010

October 16, 2004
September 29, 2010
July 2004
October 2005   (final data collection date for primary outcome measure)
The occurrence of treatment-limiting adverse events after starting study drugs.
Not Provided
Complete list of historical versions of study NCT00094367 on ClinicalTrials.gov Archive Site
  • occurrence of abacavir HSR
  • completion of educational training
  • subject satisfaction with treatment
  • adherence to study medications
  • change in HIV-1 RNA from BL
  • change in CD4 measure from BL.
Not Provided
Not Provided
Not Provided
 
A Study Comparing Safety Of Abacavir And Lamivudine Administered Once-Daily As A Single Tablet Versus The Same Drugs Administered Twice-Daily As Separate Tablets (ALOHA Study)
See Detailed Description

This study was designed to evaluate if subjects who took 600 mg of abacavir and 300 mg of lamivudine once-daily as a single tablet were just as likely to have adverse events compared to subjects who took 300 mg of abacavir and 150 mg of lamivudine administered as separate tablets twice-daily.

A phase IIIB randomized, open-label, multicenter, parallel-arm study to evaluate the short-term safety and tolerability of the abacavir/lamivudine fixed-dose combination tablet administered once-daily or the separate abacavir and lamivudine tablets administered twice-daily, as part of a three or four-drug regimen, in antiretroviral naive HIV-1 infected subjects.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infection
Drug: Abacavir/Lamivudine
Other Name: Abacavir/Lamivudine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
900
October 2005
October 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have HIV-1 infection.
  • Had not received any prior HIV treatment for more than 14 days.
  • At least 1000 copies of HIV-1 RNA.
  • Willing to provide signed informed consent.

Exclusion Criteria:

  • Enrolled in other investigational drug studies.
  • Female subjects who are pregnant or breastfeeding.
  • History of allergy or hypersensitivity to abacavir or lamivudine.
  • Certain medical conditions that would make subjects ineligible.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00094367
101822
Not Provided
Study Director, GSK
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials, PharmD GlaxoSmithKline
GlaxoSmithKline
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP