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

This study is currently recruiting participants.

Verified by Johann Wolfgang Goethe University Hospitals, July 2005

Sponsors and Collaborators:	Johann Wolfgang Goethe University Hospitals Gilead Sciences
Information provided by:	Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:	NCT00199121

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 IV

MedlinePlus related topics: AIDS

Drug Information available for: Zidovudine Tenofovir Tenofovir disoproxil Tenofovir Disoproxil Fumarate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment
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

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, Hesse
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

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

Study placed in the following topic categories:

Emtricitabine
HIV Infections
Acquired Immunodeficiency Syndrome

Tenofovir
Zidovudine
Tenofovir disoproxil

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Anti-HIV Agents
Anti-Retroviral Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Enzyme Inhibitors
Antiviral Agents
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009