Clinical trial NCT00096746: Effect of the Atazanavir (ATV) 150L Mutation on Subsequent Treatment Response in HIV Infected Subjects
Official title: An Exploratory Study of the Effect of the Atazanavir (ATV) I50L Mutation on Subsequent Treatment Response
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
Keywords: Treatment Experienced
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2004-11-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV infected individuals on first line ATV based HAART with presence of I50L mutation \& HIV infected PI naïve on failed NNRTI based regimen.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The log10 HIV RNA change from baseline for each cohort.
timeFrame: through Week 48
Secondary outcomes:
measure: Evaluate proportion of patients with plasma HIV RNA <50 copies/mL
timeFrame: at Weeks 24, 48, 72, and 96.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Local Institution
state: Arizona
city: altamonte Springs
country: United States
facility: Local Institution
state: Florida
city: Ft. Lauderdale
country: United States
facility: Local Institution
state: Florida
city: Vero Beach
country: United States
facility: Local Institution
state: Florida
city: Honolulu
country: United States
facility: Local Institution
state: Hawaii
city: Wichita
country: United States
facility: Local Instution
state: Kansas
city: Lexington
country: United States
facility: Local Instution
state: Kentucky
city: Louisville
country: United States
facility: Local Institution
state: Kentucky
city: East Orange
country: United States
facility: Local Institution
state: New Jersey
city: Albany
country: United States
facility: Local Institution
state: New York
city: Huntersville
country: United States
facility: Local Institution
state: North Carolina
city: Portland
country: United States
facility: Local Institution
state: Oregon
city: Dallas
country: United States
facility: Local Institution
state: Texas
city: Capital Federal
country: Argentina
facility: Local Institution
state: Buenos Aires
city: La Plata
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Mar Del Plata
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Rosario
country: Argentina
facility: Local Institution
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Cordoba
country: Argentina
facility: Local Institution
city: Curitiba
country: Brazil
facility: Local Institution
state: Parana
city: Recife
country: Brazil
facility: Local Institution
state: Pernambuco
city: Campinas
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Rio De Janeiro
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Guatemala
country: Guatemala
facility: Local Institution
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Durango
country: Mexico
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Port Elizabeth
country: South Africa
facility: Local Institution
state: Eastern Cape
city: Bloemfontein
country: South Africa
facility: Local Institution
state: Free State
city: Bedford Gardens
country: South Africa
facility: Local Institution
state: Gauteng
city: Johannesburg
country: South Africa
facility: Local Institution
state: Gauteng
city: Meadowdale
country: South Africa
facility: Local Institution
state: Gauteng
city: Westdene
country: South Africa
facility: Local Institution
state: Gauteng
city: Mowbray
country: South Africa
facility: Local Institution
state: Western Cape
city: Rugby
country: South Africa
facility: Local Institution
state: Western Cape
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_CHAIR
References: