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

NCT00199121 | Unknown Phase 4

• 1 other identifier: TEAZE001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Interventions

Zidovudine (drug) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johann Wolfgang Goethe University Hospital: lead
• Gilead Sciences: collaborator

Study Sites (1)

HIV Treatment & Research Unit, Dept. of Internal Medicine II, Hospital of the Johann Wolfgang Goethe University Frankfurt/Main

Frankfurt am Main, Hesse, 60590, Germany

RECRUITING

MeSH Terms

Interventions

Zidovudine; Pharmaceutical Preparations

Intervention Hierarchy (Ancestors)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Schlomo Staszewski, MD

CONTACT

+49 69 6301; stasz@hivcenter.de

Carsten Rottmann, MD

CONTACT

+49 69 6301; carstenr@hivcenter.de

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Last Updated: December 14, 2005

Record last verified: 2005-07

Locations

DE (1)