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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00043888
• Date of registration: 14/08/2002
• Prospective Registration: No
• Primary sponsor: GlaxoSmithKline
• Public title: Study to Explore Safety And Tolerability of Fosamprenavir With or Without Ritonavir in Combination With TRIZIVIR or COMBIVIR
• Scientific 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.
• Date of first enrolment: January 2002
• Target sample size: 60
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00043888
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

France, United Kingdom, United States

Contacts

• Name: GSK Clinical Trial, MD
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion 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.

- 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.



Age minimum: 13 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infections

Intervention(s)

Drug: TRIZIVIR

Drug: COMBIVIR

Drug: fosamprenavir

Drug: ritonavir

Primary Outcome(s)

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

Secondary Outcome(s)

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.

Secondary ID(s)

AZL30006

Source(s) of Monetary Support

Please refer to primary and secondary sponsors