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

HIV Infection Clinical Trial

Official title:

An Exploratory Study of the Effect of the Atazanavir (ATV) I50L Mutation on Subsequent Treatment Response

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00096746
• Other study ID #: AI424-079
• Status: Completed
• Phase: N/A
• First received: November 15, 2004
• Last updated: April 12, 2011
• Start date: November 2004
• Est. completion date: September 2006

Study information

• Verified date: April 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV Infection

Intervention

Drug:
• LPV/RTV + 2NRTIs
Tablets, Oral, Variable, Twice daily, 48 weeks.
• LPV/RTV + 2NRTIs
Tablets, Oral, Variable, Twice daily, 48 weeks.

Locations

Country	Name	City	State
Argentina	Local Institution	Buenos Aires
Argentina	Local Institution	Capital Federal	Buenos Aires
Argentina	Local Institution	Cordoba
Argentina	Local Institution	La Plata	Buenos Aires
Argentina	Local Institution	Mar Del Plata	Buenos Aires
Argentina	Local Institution	Rosario	Santa Fe
Brazil	Local Institution	Campinas	Sao Paulo
Brazil	Local Institution	Curitiba	Parana
Brazil	Local Institution	Recife	Pernambuco
Brazil	Local Institution	Rio De Janeiro
Brazil	Local Institution	Sao Paulo
Guatemala	Local Institution	Guatemala
Mexico	Local Institution	Durango
Mexico	Local Institution	Guadalajara	Jalisco
Peru	Local Institution	Lima
South Africa	Local Institution	Bedford Gardens	Gauteng
South Africa	Local Institution	Bloemfontein	Free State
South Africa	Local Institution	Johannesburg	Gauteng
South Africa	Local Institution	Meadowdale	Gauteng
South Africa	Local Institution	Mowbray	Western Cape
South Africa	Local Institution	Port Elizabeth	Eastern Cape
South Africa	Local Institution	Rugby	Western Cape
South Africa	Local Institution	Westdene	Gauteng
United States	Local Institution	Albany	New York
United States	Local Institution	altamonte Springs	Florida
United States	Local Institution	Dallas	Texas
United States	Local Institution	East Orange	New Jersey
United States	Local Institution	Ft. Lauderdale	Florida
United States	Local Institution	Honolulu	Hawaii
United States	Local Institution	Huntersville	North Carolina
United States	Local Instution	Lexington	Kentucky
United States	Local Institution	Louisville	Kentucky
United States	Local Institution	Phoenix	Arizona
United States	Local Institution	Portland	Oregon
United States	Local Institution	Vero Beach	Florida
United States	Local Instution	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Guatemala,  Mexico,  Peru,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The log10 HIV RNA change from baseline for each cohort.		through Week 48
Secondary	Evaluate proportion of patients with plasma HIV RNA <50 copies/mL		at Weeks 24, 48, 72, and 96.

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm