NCT00043888|CompletedPhase 3

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.

GlaxoSmithKline ClinicalTrials.gov

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1 other identifier

AZL30006

Study Type

interventional

Target

Locations

3 countries

Sites

Timeline

RegisteredAug 2002

StartedJan 2002

CompletionMay 2003

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_3 hiv-infections

Timeline

Completed

Started Jan 2002

Shorter than P25 for phase_3 hiv-infections

Geographic Reach

3 countries

18 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.3 years study duration

Study Start

First participant enrolled

January 1, 2002

Completed

8 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2002

Completed

5 days until next milestone

First Posted

Study publicly available on registry

August 19, 2002

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2003

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2003

Completed

Last Updated

February 12, 2013

Status Verified

February 1, 2013

Enrollment Period

1.3 years

First QC Date

August 14, 2002

Last Update Submit

February 11, 2013

Conditions

HIV Infections

Keywords

fosamprenavirritonavirCOMBIVIRTRIZIVIRabacavirlamivudinezidovudineHIVprotease inhibitors

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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.

Interventions

fosamprenavirDRUG

COMBIVIRDRUG

ritonavirDRUG

TRIZIVIRDRUG

Eligibility Criteria

Age13 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.
Treatment with radiation therapy or cytotoxic chemotherapeutic agents within 28 days of study drug administration or anticipated need for such treatment during the study.
Treatment with immunomodulating agents (such as systemic corticosteroids, interleukins, interferons) or any agent with known anti-HIV activity (such as hydroxyurea or foscarnet) within 28 days of study drug administration.
Treatment with any HIV vaccine within 3 months of study drug administration.
Treatment with other selected medications within 28 days prior to receiving study medication or the anticipated need during the study.
Current alcohol or illicit drug use which, in the opinion of the investigator, may interfere with the subject's ability to comply with the requirements of the study. Note: Subjects stabilized on methadone can be considered for participation.
+1 more criteria

Contact the study team to confirm eligibility.