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

Sponsor
Johann Wolfgang Goethe University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT00199121
Collaborator
Gilead Sciences (Industry)
1
Location

Study Details

Study Description

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 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 or Disease Intervention/Treatment Phase
  • Drug: Zidovudine (drug)
 Phase 4

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 HIV Treatment & Research Unit, Dept. of Internal Medicine II, Hospital of the Johann Wolfgang Goethe University Frankfurt/Main Frankfurt/Main Hesse Germany 60590

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00199121
    Other Study ID Numbers:
    • TEAZE001
    First Posted:
    Sep 20, 2005
    Last Update Posted:
    Dec 14, 2005
    Last Verified:
    Jul 1, 2005
    Additional relevant MeSH terms:
    Zidovudine

    Study Results

    No Results Posted as of Dec 14, 2005