Skip to main content
OpenTrials
Completed

NCT Number: NCT00363142

A Study of an Investigational Regimen Combining FDA Approved HIV Drugs in HIV-Infected Subjects

This is a 24-week study to evaluate the efficacy and safety of a once-daily ritonavir-boosted fosamprenavir regimen (1400mg/100mg QD) to a 200mg ritonavir-boosted fosamprenavir regimen administered either twice-daily or once-daily.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Ponce, Puerto Rico

Loading trial locations.

About this study

A Phase IIIB, randomized, open-label, parallel group, multi-center, non-inferiority, 24-week study to evaluate the safety, efficacy and tolerability of switching from a 200mg ritonavir-boosted regimen of LEXIVA (700mg/100mg BID or 1400mg/200mg QD) to a once-daily, 100mg ritonavir-boosted regimen of LEXIVA (1400mg/100mg QD)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects with HIV-1 infection.
  • Are willing and able to understand and provide written consent prior to participation in this study.

Exclusion criteria

  • Are pregnant or breastfeeding.
  • Have an active AIDS condition, pancreatitis, poor kidney function, or clinically relevant hepatitis.
  • Have certain medical conditions that may make participation unsafe.
  • Take medication that may interact with the study medication.
  • Have a history of allergy to any of the study drugs or any excipients therein.
  • Other inclusion/exclusion criteria to be evaluated by the physician.

Treatment and study plan

Half-boosted Fosamprenavir

Drug

Once daily, reduced dose ritonavir-boosted fosamprenavir

Full Boosted Fosamprenavir

Drug

Full ritonavir-boosted fosamprenavir

Other names: Fosamprenavir, ritonavir

Primary outcomes

  1. Percentage of Participants Not Meeting the Definition of Virologic Failure at or Prior to Week 24

    Time frame: Week 24

    Virologic failure was defined as two consecutive plasma HIV-1 RNA measures greater than 400 copies/milliliter (mL) separated by at least 2 to 4 week. The percentage of participants not meeting the virologic failure definition was estimated with stratification by the six randomization strata using Mantel-Haenszel weights and the missing/discontinuation equals failure (MD=F) analysis. Missing/discontinuation values were considered failures.

Secondary outcomes

  1. Percentage of Participants With Plasma Human Immunodeficiency Virus, Type 1, Ribonucleic Acid (HIV-1 RNA) <400 Copies/mL at Week 24, Time to Loss of Virologic Response (TLOVR) Analysis

    Time frame: Week 24

    A blood sample was drawn to determine the amount of plasma HIV-1 RNA virus in copies/mL at week 24. The percentage of participants with plasma HIV-1 RNA <400 copies/mL at Week 24 were determined by the TLOVR algorithm with stratification by the six randomization strata.

  2. Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 24, TLOVR Analysis

    Time frame: Week 24

    A blood sample was drawn to determine the amount of plasma HIV-1 RNA virus in copies/mL at week 24. The percentage of participants plasma with HIV-1 RNA <50 copies/mL at Week 24 were determined by the TLOVR algorithm with stratification by the six randomization strata.

  3. Mean Change From Baseline of log10 Copies/mL Plasma HIV-1 RNA Levels at Week 24, Observed Analysis

    Time frame: Baseline and Week 24

    A blood sample was drawn to determine the amount of plasma HIV-1 RNA virus in copies/mL at week 24. Change from baseline was defined as plasma HIV-1 RNA level at Week 24 minus plasma HIV-1 RNA level at baseline.

  4. Median Change From Baseline of CD4+ Cell Count at Week 24, Observed Analysis

    Time frame: Baseline and Week 24

    A blood sample was drawn to determine the CD4+ cell count at week 24. Change from baseline was defined as CD4+ cell count at Week 24 minus CD4+ cell count at baseline.

  5. Number of Participants Who Discontinued Treatment Due to Adverse Events Through Week 24

    Time frame: Baseline through Week 24

    The number of participants who prematurely discontinued study drug due to adverse events was tabulated. Data are summarized by individual adverse event. Adverse events were defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

  6. Number of Participants With Grade 2-4 Adverse Events Occurring in Greater Than or Equal to 2% of Subjects Through Week 24

    Time frame: Baseline through Week 24

    The number of participants who experienced any grades 2 to 4 adverse events was tabulated. Adverse events were graded based on the Division of Acquired Immunodeficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events.

  7. Percent Change From Baseline in Total Cholesterol, High Density Lipoprotein (HDL), and Triglycerides at Week 24

    Time frame: Baseline and Week 24

    A blood sample was drawn to determine the cholesterol, HDL, triglycerides levels at Week 24. Percent change in total blood cholesterol, HDL, and triglycerides was defined as (lipid level at Week 24 minus level at baseline) divided by level at baseline x 100%.

  8. Percent Change From Baseline in Low Density Lipoprotein (LDL) at Week 24

    Time frame: Baseline and Week 24

    A blood sample was drawn to determine the LDL level at Week 24. Percent change in LDL was defined as (LDL level at Week 24 minus level at baseline) divided by level at baseline x 100%.

  9. Number of Participants With Plasma HIV-1 RNA Genotypic Mutations and Phenotypic Resistance at Time of Virologic Failure Not Present at Baseline

    Time frame: Baseline through Week 24

    A blood sample was drawn for subjects failing to respond to therapy and the mutations present in the virus were identified. For each subject, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New mutations that developed at the time of virologic failure were tabulated by drug class.

  10. Steady-State Plasma Levels of Amprenavir (APV) and Ritonavir (RTV) Ctau at Weeks 12 and 24

    Time frame: Weeks 12 and 24

    Blood samples were drawn at weeks 12 and 24 to determine the plasma levels of APV and RTV. Concentration at the end of the dosing interval at steady state (Ctau) was presented.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

See Detailed Description.

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Aug 15, 2006
Registry last updated
Nov 5, 2010

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.