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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2005 by Johann Wolfgang Goethe University Hospitals.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Gilead Sciences
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00199121
First received: September 13, 2005
Last updated: December 13, 2005
Last verified: July 2005
History of Changes
  Purpose

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 Intervention Phase
HIV
 Drug: Zidovudine (drug)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: 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 NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Johann Wolfgang Goethe University Hospitals:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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 Hospitals
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

No publications provided

ClinicalTrials.gov Identifier: NCT00199121     History of Changes
Other Study ID Numbers: TEAZE001
Study First Received: September 13, 2005
Last Updated: December 13, 2005
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on May 16, 2013