Status:
COMPLETED
Switching HIV-1 Infected Subjects From a Highly Active Anti-Retroviral Treatment (HAART) Regimen Dosed Twice Daily or More Frequently to a Once-Daily Regimen
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to demonstrate that virologically controlled HIV-infected individuals can successfully switch from a standard-of-care regimen dosed twice-daily or more frequently to a sim...
Eligibility Criteria
Inclusion
- Documented HIV infection
- 18 years of age or older and weigh at least 40 kg
- Two plasma HIV RNA levels below the limit of quantification (one at least 90 days prior to the screening visit and one within 30 days of the patients baseline visit)
- Currently receiving a standard-of-care HAART regimen with at least one agent being dosed twice-daily or more frequently
Exclusion
- Pregnancy, breastfeeding or plans to become pregnant during the study period
- Any prior documented virologic failure to one or more HAART regimens
- Active AIDS-defining opportunistic infection or disease
- Proven or suspected acute hepatitis within 30 days prior to study entry
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
End Date :
July 1 2005
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00135369
Start Date
September 1 2002
End Date
July 1 2005
Last Update
April 25 2011
Active Locations (47)
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1
Local Institution
Hobson City, Alabama, United States
2
Local Institution
Montgomery, Alabama, United States
3
Local Institution
Phoenix, Arizona, United States
4
Local Institution
Little Rock, Arkansas, United States