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A Pilot Study of Triple NtRTI/NsRTI Therapy in Antiretroviral Naive HIV-1 Infected Patients

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ClinicalTrials.gov Identifier: NCT00199121
Recruitment Status : Unknown
Verified July 2005 by Johann Wolfgang Goethe University Hospital.
Recruitment status was:  Recruiting
First Posted : September 20, 2005
Last Update Posted : December 14, 2005
Sponsor:
Collaborator:
Gilead Sciences
Information provided by:
Johann Wolfgang Goethe University Hospital

Study Description
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Brief Summary:
The purpose of this study is to evaluate the antiviral effect and durability of antiviral response (HIV-1 RNA PCR) and safety of a triple NtRTI/NsRTI therapy in antiretroviral naive patients. Patients will receive TDF plus FTC plus AZT for at least 48 weeks. Further objectives are to evaluate resistance pathways in failing patients treated with TDF/FTC/AZT and to evaluate a treatment strategy of sparing PIs and NNRTIs for later treatment.

Condition or disease Intervention/treatment Phase
HIV Drug: Zidovudine (drug) Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open, Single-Arm, Multi-Center, Phase IV Pilot Study of Treatment of Antiretroviral Naive HIV-1 Infected Patients With Tenofovir Disoproxil Fumarate in Combination With Emtricitabine and Zidovudine

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Zidovudine

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years and older
  • HIV-1 positive
  • antiretroviral treatment naive
  • one CD4 count >200/ul within 14d prior to study drug administration
  • one HIV-1 RNA PCR value >5000 and <100.000 cop/ml within 14d prior to study drug administration
  • women of child bearing potential: negative serum pregnancy test within 14d of study
  • ability to understand and provide written informed consent
  • overall stable disease
  • absence of clinical signs of lipodystrophy

Exclusion Criteria:

  • alcohol or illicit drug use
  • malabsorption syndrome or other gastrointestinal dysfunction
  • clinically relevant pancreatitis/hepatitis within the last 6 months
  • receiving other investigational drugs
  • abnormal hemoglobin, neutrophil, platelet, AST/ALT, pancreatic amylase, creatinine clearance, total bilirubine levels within 14d prior to study
  • pregnancy/breast-feeding
  • radiation therapy or cytotoxic chemotherapeutic agents within 30d of study
  • prior antiretroviral therapy at any time, investigational antiretrovirals trial at any time, HIV vaccine within 90d prior to study
  • immunomodulating agents
  • serious medical condition (diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction)
  • active diagnosis of AIDS (except for cutaneous Kaposi Sarcoma)
  • foscarnet therapy or other agent with documented activity against HIV-1
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00199121


Contacts
Contact: Schlomo Staszewski, MD +49 69 6301 ext 7680 stasz@hivcenter.de
Contact: Carsten Rottmann, MD +49 69 6301 ext 7680 carstenr@hivcenter.de

Locations
Germany
HIV Treatment & Research Unit, Dept. of Internal Medicine II, Hospital of the Johann Wolfgang Goethe University Frankfurt/Main Recruiting
Frankfurt/Main, Hesse, Germany, 60590
Contact: Axel W. Müller, MD    +49 69 6301 ext 7680    muellera@hivcenter.de   
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Gilead Sciences
Investigators
Principal Investigator: Schlomo Staszewski, MD Head of the HIV Treatment & Research Unit, Dept. of Internal Medicine II, Hospital of the Johann Wolfgang Goethe University Frankfurt/Main, Germany
More Information
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ClinicalTrials.gov Identifier: NCT00199121     History of Changes
Other Study ID Numbers: TEAZE001
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: December 14, 2005
Last Verified: July 2005

Additional relevant MeSH terms:
Zidovudine
Tenofovir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
 Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents