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

Completed · Phase 3

Conditions studied: HIV Infections

In brief

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 simpler once-daily (QD) regimen while maintaining virologic control, as evaluated by the proportion of subjects who continue to have plasma HIV-1 levels \<50 copies/mL after switching to a QD regimen.

Key facts

Study ID

NCT00135369

Run by

Bristol-Myers Squibb

People needed

300

Starts

2002-09-01

Expected to finish

2005-07-01

Last updated by the study team

2011-04-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Local Institution — Hobson City, Alabama, United States
• Local Institution — Montgomery, Alabama, United States
• Local Institution — Phoenix, Arizona, United States
• Local Institution — Little Rock, Arkansas, United States
• Local Institution — Los Angeles, California, United States
• Local Institution — Sacramento, California, United States
• Local Institution — San Mateo, California, United States
• Local Institution — Torrance, California, United States
• Local Institution — Denver, Colorado, United States
• Local Institution — Norwalk, Connecticut, United States
• Local Institution — Stratford, Connecticut, United States
• Local Institution — Washington D.C., District of Columbia, United States
• Local Institution — Fort Lauderdale, Florida, United States
• Local Institution — Miami, Florida, United States
• Local Institution — Miami Beach, Florida, United States
• Local Institution — Pensacola, Florida, United States
• Local Institution — Tampa, Florida, United States
• Local Institution — Decatur, Georgia, United States
• Local Institution — Chicago, Illinois, United States
• Local Institution — Indianapolis, Indiana, United States
• Local Institution — New Orleans, Louisiana, United States
• Local Institution — Baltimore, Maryland, United States
• Local Institution — Boston, Massachusetts, United States
• Local Institution — Berkley, Michigan, United States
• Local Institution — Detroit, Michigan, United States

Full record on ClinicalTrials.gov

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