Status:
UNKNOWN
A Pilot Study of Triple NtRTI/NsRTI Therapy in Antiretroviral Naive HIV-1 Infected Patients
Lead Sponsor:
Johann Wolfgang Goethe University Hospital
Collaborating Sponsors:
Gilead Sciences
Conditions:
HIV
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00199121
Last Update
December 14 2005
Active Locations (1)
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1
HIV Treatment & Research Unit, Dept. of Internal Medicine II, Hospital of the Johann Wolfgang Goethe University Frankfurt/Main
Frankfurt am Main, Hesse, Germany, 60590