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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

September 13, 2005
December 13, 2005
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Complete list of historical versions of study NCT00199121 on ClinicalTrials.gov Archive Site
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A Pilot Study of Triple NtRTI/NsRTI Therapy in Antiretroviral Naive HIV-1 Infected Patients
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

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.

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Interventional
Phase 4
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV
Drug: Zidovudine (drug)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
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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
Both
18 Years and older
No
Contact: Schlomo Staszewski, MD +49 69 6301 ext 7680 stasz@hivcenter.de
Contact: Carsten Rottmann, MD +49 69 6301 ext 7680 carstenr@hivcenter.de
Germany
 
NCT00199121
TEAZE001
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Johann Wolfgang Goethe University Hospitals
Gilead Sciences
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
Johann Wolfgang Goethe University Hospitals
July 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP