Effect of the Atazanavir (ATV) 150L Mutation on Subsequent Treatment Response in HIV Infected Subjects

Completed

Conditions studied: HIV Infection

In brief

This study will compare the response of subjects who failed a first-line ATV-containing regimen and who have the 150L-containing virus to subsequent protease inhibitor (PI)-containing therapy with that of a cohort who has failed a first-line reverse transcriptase inhibitor (NNRTI), and is subsequently receiving PI-containing therapy.

Key facts

Study ID

NCT00096746

Run by

Bristol-Myers Squibb

People needed

200

Starts

2004-11-01

Expected to finish

2006-09-01

Last updated by the study team

2011-04-13

Who can join

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

You may qualify if…

• Currently on a first-line antiretroviral regimen containing ATV with a confirmed rebound and a genotype that verifies the presence of an 150L mutation OR on a first-line regimen containing an NNRTI and PI-naive, with a confirmed rebound

You may not qualify if…

• Women of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the study.
• Women who are pregnant or breastfeeding.
• A life expectancy of <12 months.
• Presence of a newly diagnosed HIV-related opportunistic infection or any other medical condition requiring acute therapy at the time of enrollment.
• Active alcohol or substance abuse sufficient, in the investigator's opinion, to prevent adequate adherence to study therapy or to increase the risk of developing pancreatitis or chemical hepatitis.

Where it is running

• Local Institution — Phoenix, Arizona, United States
• Local Institution — Altamonte Springs, Florida, United States
• Local Institution — Fort Lauderdale, Florida, United States
• Local Institution — Vero Beach, Florida, United States
• Local Institution — Honolulu, Hawaii, United States
• Local Instution — Wichita, Kansas, United States
• Local Instution — Lexington, Kentucky, United States
• Local Institution — Louisville, Kentucky, United States
• Local Institution — East Orange, New Jersey, United States
• Local Institution — Albany, New York, United States
• Local Institution — Huntersville, North Carolina, United States
• Local Institution — Portland, Oregon, United States
• Local Institution — Dallas, Texas, United States
• Local Institution — Buenos Aires, Buenos Aires, Argentina
• Local Institution — Capital Federal, Buenos Aires, Argentina
• Local Institution — La Plata, Buenos Aires, Argentina
• Local Institution — Mar del Plata, Buenos Aires, Argentina
• Local Institution — Córdoba, Córdoba Province, Argentina
• Local Institution — Rosario, Santa Fe Province, Argentina
• Local Institution — Buenos Aires, Argentina
• Local Institution — Curitiba, Paraná, Brazil
• Local Institution — Recife, Pernambuco, Brazil
• Local Institution — Rio de Janeiro, Rio de Janeiro, Brazil
• Local Institution — Campinas, São Paulo, Brazil
• Local Institution — São Paulo, Brazil

Full record on ClinicalTrials.gov

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