A Phase IIIb/IV, Randomized, Open Label, Multicenter, Pilot Trial to Explore the Safety and Tolerability of GW433908 +/- Ritonavir (1400mg Twice Daily or 700mg/100mg Twice Daily) When Used in Combination With a Zidovudine-containing Regimen (TRIZIVIR or COMBIVIR Twice Daily) Over a 24 Week Period in Antiretroviral Therapy Naive HIV-1 Infected Subjects.

GlaxoSmithKline1 site in 1 country60 target enrollmentJanuary 2002

ConditionsHIV Infections

Drugsfosamprenavir COMBIVIR ritonavir TRIZIVIR

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: HIV Infections
Sponsor: GlaxoSmithKline
Enrollment: 60
Locations: 1
Primary Endpoint: To assess the overall short term tolerance of the regimens under investigation
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Antiretroviral Therapy (ART) naive subjects will be enrolled in this clinical research study to test the safety and tolerability of fosamprenavir with or without ritonavir in combination TRIZIVIR and COMBIVIR. Subjects will receive 24 weeks of therapy.

Registry

clinicaltrials.gov

Start Date

January 2002

End Date

May 2003

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Eligibility Criteria

Inclusion Criteria

•Lab result for Screening viral load (HIV-1 RNA) greater than or equal to 1,000 copies per mL.
•Lab result for Screening CD4 cell count greater than or equal to 100 cells per microliter.
•Antiretroviral therapy naive (no prior therapy allowed).
•Male or female 13 years of age or older (or 18 years of age or older according to local requirements).
•Female subjects must be of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including women who are post-menopausal) or of child-bearing potential with a negative blood pregnancy test at screen and who agree to use a proven barrier method of contraception (e.g. spermicide plus condom) during the study period. Hormonal contraceptives will not be considered sufficient forms of contraception for this study. All subjects participating in this study should be counselled on the practice of safe or safer sex.
•Able to understand and provide written informed consent to participate in this trial. Parental or guardian consent must also be obtained for subjects under the age of 18 years.

Exclusion Criteria

•Prior history of having received antiretroviral therapy.
•An active HIV Associated Disease (Center for Disease Control Category C) within 28 days of study drug administration.
•Any sudden onset or sharp rise in a laboratory abnormality (including abnormally high laboratory values) at Screening that causes the investigator to have the opinion that the subject should not participate in the study of an investigational compound.
•Subjects with a laboratory result for estimated creatinine clearance less than 40 ml per minute within 28 days of study drug administration.
•Laboratory result for serum aminotransferase (AST, ALT) levels elevated greater than five to ten times (or more) the upper limit of the normal range within 28 days prior to study drug administration.
•Pregnant or lactating women.
•History of clinically relevant pancreatitis or hepatitis within 6 months of study drug administration.
•Presence of any serious medical condition (e.g., diabetes, cardiac dysfunction, hepatitis) which, in the opinion of the investigator, might compromise the safety of the subject.
•Presence of a malabsorption syndrome or other gastrointestinal dysfunction which might interfere with drug absorption or render the subject unable to take oral medication.
•History of a drug or other allergy which, in the opinion of the investigator, contraindicates the subject's participation in the study.

Outcomes

Primary Outcomes

To assess the overall short term tolerance of the regimens under investigation

Secondary Outcomes

Nature and incidence of laboratory abnormality; impact/burden of adverse events to subjects; plasma zidovudine (ZDV)pharmacokinetic parameters; change from baseline in plasma HIV-1 RNA levels over time.