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Completed

NCT Number: NCT00296504

A Study To Assess GW433908 (Fosamprenavir) Containing Regimens In HIV-1 Infected Subjects

GW433908 (fosamprenavir; FPV)is a pro-drug of amprenavir (APV) which is more water soluble and can be formulated into a tablet with a reduced pill burden (four 700mg tablets of FPV versus sixteen 150mg capsules daily for APV. This study is designed to provide additional information on long term safety and tolerability of FPV containing regimens for those subjects who received FPV in previous GlaxoSmithKline studies.

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Key information

Conditions

Infection, Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Campinas, São Paulo, Brazil

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About this study

ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or non-pregnant/non-lactating females >/=13 years of age (or >/= 18 years of age according to local requirements).
  • Received fosamprenavir through prior participation in APV20001, APV30002, APV30003 or PRO30017 or have participated in APV30001 or other studies as deemed appropriate by the project team.

Exclusion criteria

  • Permanent discontinuation of GW433908 in a previous study due to intolerance.
  • An active CDC Class C Event.
  • Any condition which, in the opinion of the investigator, would preclude a subject from participation.

Treatment and study plan

fosamprenavir (GW433908)

Drug

Ritonavir

Drug

Other names: fosamprenavir (GW433908)

Primary outcomes

  1. Number of Participants With Any Adverse Event (AE): Interim Analysis

    Time frame: Baseline (Day 1) up to 31 January 2006 (up to Week 264)

    An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the "Other (Non-Serious) Adverse Events" section.

  2. Number of Participants With Any Adverse Event (AE): Final Analysis

    Time frame: Post January 2006; for up to 241 weeks

    An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the "Other (Non-Serious) Adverse Events" section.

  3. Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216

    Time frame: Baseline (Day 1) and Weeks 48, 96, 120, 132, 168, 180, 204, and 216

    Fasting blood samples of participants were collected for the assessment of triglycerides (Tri.), cholesterol (Chol.), high density cholesterol (HDL), low density cholesterol (LDL), and fasting blood glucose (FBG). Change from Baseline at Weeks (W) 48, 96, 120, 132, 168, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).

  4. Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432

    Time frame: Weeks 120, 180, 204, 216, and 432

    Fasting blood samples of participants were collected for the assessment of triglycerides, cholesterol, high density cholesterol (HDL), low density cholesterol (LDL), and fasting blood glucose (FBG).

  5. Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216

    Time frame: Baseline (Day 1) and Weeks 48, 120, 180, 204, and 216

    blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL. Change from Baseline at Weeks 48, 120, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).

  6. Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 96, 132, and 168

    Time frame: Baseline (Day 1) and Weeks 48, 96, 132, and 168

    Fasting blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL. Change from Baseline at Weeks 48, 96, 132, and 168 was calculated as the value at that particular week minus the value at Baseline (Day 1).

  7. Median Value of the Total Cholesterol/HDL Ratio at Weeks 120, 180, 204, 216, and 432

    Time frame: Weeks 120, 180, 204, 216, and 432

    Fasting blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL.

  8. Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216

    Time frame: Baseline (Day 1) and Weeks 48, 120, 180, 204, and 216

    Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase. Change from Baseline at Weeks 48, 120, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).

  9. Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168

    Time frame: Baseline (Day 1) and Weeks 48, 96, 132, and 168

    Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase. Change from Baseline at Weeks 48, 96, 132, and 168 was calculated as the value at that particular week minus the value at Baseline (Day 1).

  10. Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432

    Time frame: Weeks 120, 180, 204, 216, and 432

    Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase.

Secondary outcomes

  1. Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed)

    Time frame: Baseline and Weeks 48, 120, 180, and 216

    Blood samples of participants were collected for the assessment of HIV-1RNA copies in plasma. Viral load, measured in RNA copies per milliliter of plasma, is an efficacy measure for antiretroviral drugs. In the MD=F analysis, participants who had missing data at or had discontinued the study prior to a certain time point are classified as non-responders. In the observed analysis (OA), data are presented for the number of participants still enrolled in the study at a certain time point. Participants in the NFV populations had received antiretroviral therapy prior to Baseline.

  2. Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed)

    Time frame: Baseline and Weeks 12, 24, 48, 60, 96, and 132

    Blood samples of participants were collected for the assessment of HIV-1RNA copies in plasma. Viral load, measured in RNA copies per milliliter of plasma, is an efficacy measure for antiretroviral drugs. In the MD=F analysis, participants who had missing data at or had discontinued the study prior to a certain time point are classified as non-responders. In the observed analysis (OA), data are presented for the number of participants still enrolled in the study at a certain time point.

  3. Percentage of Participants With Plasma HIV-1RNA <50 Copies Per Milliliter at Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432 (Observed)

    Time frame: Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432

    Blood samples of participants were collected for the assessment of HIV-1RNA copies in plasma. Viral load, measured in RNA copies per milliliter of plasma,is an efficacy measure for antiretroviral drugs.

  4. Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis

    Time frame: Baseline and Weeks 48, 120, 168, 180, 204, and 216

    Blood samples of participants were collected for the assessment of CD4+ cell count. CD4+ cells are white blood cells that are important in fighting infection. HIV infects CD4+ cells, replicates in them, and destroys them. CD4+ cell count provides a measure of the status of the immune system and to what extent it is affected by HIV.

  5. Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis

    Time frame: Baseline and Weeks 24, 48, 96, 132, and 168

    Blood samples of participants were collected for the assessment of CD4+ cell count. CD4+ cells are white blood cells that are important in fighting infection. HIV infects CD4+ cells, replicates in them, and destroys them. CD4+ cell count provides a measure of the status of the immune system and to what extent it is affected by HIV.

  6. Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216

    Time frame: Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216

    Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.

  7. Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168

    Time frame: Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168

    Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.

  8. Median Plasma HIV-1 RNA at Weeks 180, 240, 300, 360, 420, and 432

    Time frame: Weeks 180, 240, 300, 360, 420, and 432

    Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.

  9. Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline

    Time frame: Baseline (Day 1) up to 31 January 2006 (up to Week 264)

    The number of participants with progression of HIV-1 disease were assessed using the CDC classification of HIV-1: class A, asymptomatic or lymphadenopathy; class B: symptomatic, but not AIDS; class C, AIDS. A participant is considered to have had a disease progression if they report a CDC Class C event for the first time, if they report a new CDC Class C event, or if they experience any fatal adverse event during the study.

  10. Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions

    Time frame: Baseline (Day 1) up to 31 January 2006 (up to Week 264)

    The number of participants with the indicated HIV-associated conditions were assessed, excluding recurrences.

  11. Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions

    Time frame: Baseline (Day 1) up to 31 January 2006 (up to Week 264)

    The number of participants with the indicated HIV-associated conditions were assessed.

Sponsors and collaborators

Lead sponsor

ViiV Healthcare

Industry

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

An Open-Label Phase III Study to Assess the Long Term Safety Profile of GW433908 Containing Regimens in HIV-1 Infected Subjects

Important dates

Study start
2001
Primary completion
2010
Study completion
2010
First posted
Feb 27, 2006
Registry last updated
Apr 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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