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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified July 2005 by Johann Wolfgang Goethe University Hospital.
Recruitment status was: Recruiting

Sponsor:

Collaborator:

Gilead Sciences

Information provided by:

Johann Wolfgang Goethe University Hospital

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

Drug Information available for: Zidovudine

U.S. FDA Resources

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

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

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: 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


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

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on June 27, 2017

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