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

HIV Infections Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00043888
• Other study ID #: AZL30006
• Status: Completed
• Phase: Phase 3
• First received: August 14, 2002
• Last updated: February 11, 2013
• Start date: January 2002
• Est. completion date: May 2003

Study information

• Verified date: February 2013
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2003
• Est. primary completion date: May 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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.

• 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.

• Treatment with other investigational drugs or therapies within 28 days prior to Day 1, or an anticipated need for such treatment during the study. Treatments available through a Treatment IND or other expanded-access mechanism will be evaluated on a case-by-case basis.

• Other inclusion or exclusion criteria to be determined by the investigator and sponsor of the study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• fosamprenavir

• COMBIVIR

• ritonavir

• TRIZIVIR

Locations

Country	Name	City	State
France	GSK Clinical Trials Call Center	Lyon
France	GSK Clinical Trials Call Center	Paris
France	GSK Clinical Trials Call Center	Paris
United Kingdom	GSK Clinical Trials Call Center	London
United Kingdom	GSK Clinical Trials Call Center	Manchester
United States	GSK Clinical Trials Call Center	Altamonte Springs	Florida
United States	GSK Clinical Trials Call Center	Atlanta	Georgia
United States	GSK Clinical Trials Call Center	Denver	Colorado
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	GSK Clinical Trials Call Center	Greenville	North Carolina
United States	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	Philadelphia	Pennsylvania
United States	GSK Clinical Trials Call Center	San Diego	California
United States	GSK Clinical Trials Call Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  France,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the overall short term tolerance of the regimens under investigation
Secondary	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.