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A RANDOMIZED OPEN-LABEL STUDY OF THE ANTIVIRAL EFFICACY AND SAFETY OF ATAZANAVIR VERSUS LOPINAVIRHHTONAVIR (LPV/RTV), EACH IN COMBINATION WITH TWO NUCLEOSIDES IN SUBJECTS WHO HAVE EXPERIENCED VIROLOGIC FAILURE WITH PRIOR PROTEASE INHIBITOR-CONTAINING HAART REGIIVIEN(S)

A RANDOMIZED OPEN-LABEL STUDY OF THE ANTIVIRAL EFFICACY AND SAFETY OF ATAZANAVIR VERSUS LOPINAVIRHHTONAVIR (LPV/RTV), EACH IN COMBINATION WITH TWO NUCLEOSIDES IN SUBJECTS WHO HAVE EXPERIENCED VIROLOGIC FAILURE WITH PRIOR PROTEASE INHIBITOR-CONTAINING HAART REGIIVIEN(S)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-001-02
Enrollment
220
Registered
2002-01-07
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Group I Type of group
Treatment Group I will receive open label atazanavir 400 mg QD, in addition to a permitted NRTI pair. Group name:GROUP II Type of group
Subjects assigned to Treatment Group II will receive open label LPV/RTV 400/100 mg BID.

Sponsors

BRISTOL MYERS SQUIBB PERU S.A.,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Subjects will be HlV-infected, wili have failed prior antiretroviral treatment(s) which must have included ene PI, will have a plasma HIV RNA viral load > 1,000 c/mL (Roche Amplicor®) and have a CD4 cell count of > 50 cells/mm3

Exclusion criteria

Exclusion criteria: Subjects will be excluded if they have prior exposure and reported virologic failure to two or more protease inhibitors (> 30 days of protease inhibitor therapy) and if they have prior use of atazanavir or lopinavir/ritonavir.

Countries

Argentina, Australia, Brazil, Canada, Chile, Denmark, Finland, France, Italy, Mexico, Netherlands, Poland, Puerto Rico, Spain, United Kindgdom, United States

Outcome results

None listed

Source: REPEC (via WHO ICTRP)