GW873140 In Combination With Kaletra In HIV Infected Subjects - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00102778

Purpose

This study is a 96-week study designed to evaluate the safety and efficacy of GW873140 in combination with Kaletra in HIV infected, untreated subjects.

Condition	Intervention	Phase
HIV Infection	Drug: Kaletra (lopinavir/ritonavir) Drug: GW873140	Phase II

MedlinePlus related topics: AIDS

Drug Information available for: Ritonavir Lopinavir Aplaviroc

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Open Label, Parallel Assignment, Randomized, Safety/Efficacy Study, Treatment
Official Title:	See Detailed Description

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

To select a GW873140 dose and dosage regimen for further evaluation based on comparison of the short-term antiviral activity, safety and tolerability of different oral doses of GW873140 in combination with LPV/r in HIV-1 infected therapy-naive subjects.

Secondary Outcome Measures:

HIV-1 RNA decay rate Long-term safety Effects on plasma viral tropism Viral resistance to GW873140 and other on-study drugs PK parameters of GW873140 in subjects receiving combination therapy.

Estimated Enrollment:	175
Study Start Date:	December 2004

Detailed Description:

A Phase IIb, 96 week, randomized, open-label, multicenter, parallel group, repeat dose study to evaluate the safety, tolerability, pharmacokinetics and antiviral effect of different doses and regimens of GW873140 in combination with Kaletra (lopinavir and ritonavir) in HIV-1 infected antiretroviral therapy naive subjects

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

HIV infected, therapy-naive subjects.
Females must be of either non-childbearing age, or have a negative pregnancy test.
All subjects participating in this study should be counseled on the practice of safe sex using a proven double barrier method of contraception throughout the study.
Screening lab result of plasma HIV-1 RNA greater than or equal to 50,000 copies/mL and CD4 cell count greater than or equal to 100 cells/mm3.
Have CC Chemokine Receptor5-tropic (R5-tropic) or CC Chemokine Receptor5/CXC Chemokine Receptor4-tropic (R5/X4-tropic) virus based on viral tropism test at screening visit.
Be treatment-naive, defined as less than or equal to 2 weeks of treatment with a protease inhibitor (PI) or an nucleoside reverse transcriptase inhibitor/nucleotide reverse transcriptase inhibitor (NRTI/ NtRTI), or less than or equal to 7 days of therapy with a non-nucleoside reverse transcriptase inhibitor (NNRTI).
Prior treatment with any entry inhibitor, attachment inhibitor, or fusion inhibitor (experimental or approved) is not allowed.
Be able to understand and follow with protocol requirements, instructions and protocol-stated restrictions.
Signed and dated written informed consent prior to study entry.

Exclusion criteria:

No detection of CXC Receptor4-tropic (X4-tropic) virus only, based on viral tropism test at screening.
No active Class C AIDS-defining illness.
No laboratory abnormalities at screen.
No significant blood loss prior to study start.
No pregnant or breastfeeding women.
Additional qualifying criteria to be determined by the physician.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00102778

Show 70 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	100136
Study First Received:	February 1, 2005
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00102778 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

HIV infected
therapy-naive subjects

Study placed in the following topic categories:

Sexually Transmitted Diseases, Viral
HIV Protease Inhibitors
Anti-HIV Agents
Acquired Immunodeficiency Syndrome
Antiviral Agents
Immunologic Deficiency Syndromes
Protease Inhibitors

Virus Diseases
Lopinavir
Anti-Retroviral Agents
HIV Infections
Ritonavir
Sexually Transmitted Diseases
Retroviridae Infections

Additional relevant MeSH terms:

Anti-Infective Agents
HIV Protease Inhibitors
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Infection
Antiviral Agents

Pharmacologic Actions
Immunologic Deficiency Syndromes
Protease Inhibitors
Virus Diseases
Anti-Retroviral Agents
Lopinavir
HIV Infections
Ritonavir
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on March 13, 2009