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Monotherapy Versus Placebo Over 7 Days-Non-Nucleoside Reverse Transcriptase Inhibitor-Experienced HIV1 Infected Adults

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00090077
First received: August 24, 2004
Last updated: February 24, 2006
Last verified: February 2006
  Purpose

To investigate safety, tolerability and antiviral activity in Non-nucleoside reverse transcriptase inhibitor (NNRTI)-experienced HIV-1 infected patients


Condition Intervention Phase
HIV Infections
Drug: GW695634
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase I, Multicenter, Randomized, Parallel, Double-Blinded Dose Ranging, Placebo-Controlled Study to Compare Antiviral Effect, Safety, Tolerability and Pharmacokinetics of Four Oral Dosage Regimens of GW695634G Monotherapy Versus Placebo Over 10 Days in ART-Naive HIV-1 Infected Adults.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Safety & tolerability parameters Change from baseline in plasma HIV-1 RNA Change from baseline in CD4+ cell count Plasma GW678248X pharmacokinetic parameters Days 1 & 7

Secondary Outcome Measures:
  • Plasma GW695634X pharmacokinetic parameters on Day 1 and Day 7 Exploratory relationship of pharmacokinetic parameters to changes in virology, immunology and/or safety assessments

Estimated Enrollment: 50
Study Start Date: April 2004
  Eligibility

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

Inclusion criteria:

  • CD4 cell count greater than or equal to 200 cells/mm3.
  • HIV-1 RNA >2000 copies/mL.
  • Must have history of NNRTI treatment with subsequent failure and documented evidence of an NNRTI-associated mutation or a phenotype displaying reduced activity to efavirenz, nevirapine or delavirdine.
  • Normal resting 12-lead electrocardiogram.

Exclusion criteria:

  • Any history of seizure, CNS toxoplasmosis infection, or any CNS (central nervous system) lesion.
  • Chronic diarrhea (>3 loose stools/day).
  • An active CDC Category C disease (1993), except cutaneous Kaposi's Sarcoma (KS) not requiring systemic therapy during the trial.
  • Less than 4 weeks since stopping anti-retroviral therapy (ART) therapy prior to Day 1.
  • Any acute laboratory abnormality.
  • Positive for HCV antibody or HepBsAG.
  • Active infections requiring therapy in the previous 4 weeks.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090077

Locations
United States, Arizona
GSK Clinical Trials Call Center
Phoenix, Arizona, United States, 85006
United States, California
GSK Clinical Trials Call Center
Fountain Valley, California, United States, 92708
GSK Clinical Trials Call Center
San Francisco, California, United States, 94115
GSK Clinical Trials Call Center
West Hollywood, California, United States, 90069
United States, District of Columbia
GSK Clinical Trials Call Center
Washington, District of Columbia, United States, 20007
United States, Florida
GSK Clinical Trials Call Center
Fort Lauderdale, Florida, United States, 33308
GSK Clinical Trials Call Center
Miami, Florida, United States, 33136
GSK Clinical Trials Call Center
Miami Beach, Florida, United States, 33140
GSK Clinical Trials Call Center
Orlando, Florida, United States, 32804
GSK Clinical Trials Call Center
Vero Beach, Florida, United States, 32960
United States, Georgia
GSK Clinical Trials Call Center
Atlanta, Georgia, United States, 30308
United States, Massachusetts
GSK Clinical Trials Call Center
Boston, Massachusetts, United States, 02215
United States, Nevada
GSK Clinical Trials Call Center
Las Vegas, Nevada, United States, 89102
United States, New York
GSK Clinical Trials Call Center
New York, New York, United States, 10008
United States, North Carolina
GSK Clinical Trials Call Center
Charlotte, North Carolina, United States, 28209
United States, Oklahoma
GSK Clinical Trials Call Center
Oklahoma City, Oklahoma, United States, 73104
United States, Texas
GSK Clinical Trials Call Center
Fort Worth, Texas, United States, 76104
United States, Washington
GSK Clinical Trials Call Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trial, MD GlaxoSmithKline
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00090077     History of Changes
Other Study ID Numbers: NN210005
Study First Received: August 24, 2004
Last Updated: February 24, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
GW695634G
GW695634X
GW678248X
pharmacokinetics
NNRTI
HIV

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Reverse Transcriptase Inhibitors
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014