- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00199121
A Pilot Study of Triple NtRTI/NsRTI Therapy in Antiretroviral Naive HIV-1 Infected Patients
December 13, 2005 updated by: Johann Wolfgang Goethe University Hospital
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.
Study Overview
Study Type
Interventional
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hesse
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Frankfurt/Main, Hesse, Germany, 60590
- Recruiting
- HIV Treatment & Research Unit, Dept. of Internal Medicine II, Hospital of the Johann Wolfgang Goethe University Frankfurt/Main
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Contact:
- Axel W. Müller, MD
- Phone Number: 7680 +49 69 6301
- Email: muellera@hivcenter.de
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 20, 2005
Study Record Updates
Last Update Posted (Estimate)
December 14, 2005
Last Update Submitted That Met QC Criteria
December 13, 2005
Last Verified
July 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TEAZE001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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