A Pilot Study of Triple NtRTI/NsRTI Therapy in Antiretroviral Naive HIV-1 Infected Patients
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ClinicalTrials.gov Identifier: NCT00199121 |
Recruitment Status
: Unknown
Verified July 2005 by Johann Wolfgang Goethe University Hospital.
Recruitment status was: Recruiting
First Posted
: September 20, 2005
Last Update Posted
: December 14, 2005
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV | Drug: Zidovudine (drug) | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
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 |


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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00199121
Contact: Schlomo Staszewski, MD | +49 69 6301 ext 7680 | stasz@hivcenter.de | |
Contact: Carsten Rottmann, MD | +49 69 6301 ext 7680 | carstenr@hivcenter.de |
Germany | |
HIV Treatment & Research Unit, Dept. of Internal Medicine II, Hospital of the Johann Wolfgang Goethe University Frankfurt/Main | Recruiting |
Frankfurt/Main, Hesse, Germany, 60590 | |
Contact: Axel W. Müller, MD +49 69 6301 ext 7680 muellera@hivcenter.de |
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 |
ClinicalTrials.gov Identifier: | NCT00199121 History of Changes |
Other Study ID Numbers: |
TEAZE001 |
First Posted: | September 20, 2005 Key Record Dates |
Last Update Posted: | December 14, 2005 |
Last Verified: | July 2005 |
Additional relevant MeSH terms:
Zidovudine Tenofovir Antimetabolites Molecular Mechanisms of Pharmacological Action Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |
Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents |