A Pilot Study of Triple NtRTI/NsRTI Therapy in Antiretroviral Naive HIV-1 Infected Patients
NCT ID: NCT00199121
Last Updated: 2005-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Zidovudine (drug)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Johann Wolfgang Goethe University Hospital
OTHER
Principal Investigators
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Schlomo Staszewski, MD
Role: PRINCIPAL_INVESTIGATOR
Head of the HIV Treatment & Research Unit, Dept. of Internal Medicine II, Hospital of the Johann Wolfgang Goethe University Frankfurt/Main, Germany
Locations
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HIV Treatment & Research Unit, Dept. of Internal Medicine II, Hospital of the Johann Wolfgang Goethe University Frankfurt/Main
Frankfurt am Main, Hesse, Germany
Countries
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Central Contacts
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Facility Contacts
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Axel W. Müller, MD
Role: primary
Other Identifiers
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TEAZE001
Identifier Type: -
Identifier Source: org_study_id