A Pilot Study of Triple NtRTI/NsRTI Therapy in Antiretroviral Naive HIV-1 Infected Patients
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ClinicalTrials.gov Identifier: NCT00199121
Verified July 2005 by Johann Wolfgang Goethe University Hospital. Recruitment status was: Recruiting
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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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
18 years and older
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
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
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
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