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Study to Explore Safety And Tolerability of Fosamprenavir With or Without Ritonavir in Combination With TRIZIVIR or COMBIVIR | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Study to Explore Safety And Tolerability of Fosamprenavir With or Without Ritonavir in Combination With TRIZIVIR or COMBIVIR

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.

NCT00043888•GlaxoSmithKline

View on ClinicalTrials.gov

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.

Eligibility

Age

13 - No limit years

Sex

ALL

Healthy Volunteers

No

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.
+6 more criteria

Locations (18)

GSK Clinical Trials Call Center

Little Rock, Arkansas, United States

GSK Clinical Trials Call Center

Long Beach, California, United States

GSK Clinical Trials Call Center

Newport Beach, California, United States

GSK Clinical Trials Call Center

San Diego, California, United States

GSK Clinical Trials Call Center

Denver, Colorado, United States

GSK Clinical Trials Call Center

Washington D.C., District of Columbia, United States

GSK Clinical Trials Call Center

Altamonte Springs, Florida, United States

GSK Clinical Trials Call Center

Fort Lauderdale, Florida, United States

GSK Clinical Trials Call Center

Fort Lauderdale, Florida, United States

GSK Clinical Trials Call Center

Fort Lauderdale, Florida, United States

Key Dates

Start Date

January 1, 2002

Primary Completion Date

May 1, 2003

Completion Date

May 1, 2003

Last Updated

February 12, 2013

Enrollment

60

Estimated participants

Conditions

HIV Infections

Interventions

fosamprenavir

DRUG

COMBIVIR

DRUG

ritonavir

DRUG

TRIZIVIR

DRUG

Sponsors

Lead Sponsor

GlaxoSmithKline

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 12, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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