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)
Recruiting in Palo Alto (17 mi)
+124 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: GlaxoSmithKline
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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.
Research Team
GC
GSK Clinical Trials, PharmD
Principal Investigator
GlaxoSmithKline
Eligibility Criteria
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.
See 1 more
Treatment Details
Interventions
- Abacavir (Nucleoside Reverse Transcriptase Inhibitor)
- Lamivudine (Nucleoside Reverse Transcriptase Inhibitor)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
GSK Investigational SiteGlastonbury, CT
GSK Investigational SiteNew Haven, CT
GSK Investigational SiteDecatur, GA
GSK Investigational SiteBaltimore, MD
More Trial Locations
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Who Is Running the Clinical Trial?
GlaxoSmithKline
Lead Sponsor
Trials
4834
Patients Recruited
8,389,000+
Headquarters
London, UK
Known For
Vaccines & Medicines
Top Products
**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)