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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00449436 |
Purpose
The current goal of antiretroviral therapy is to use a potent regimen that will suppress plasma viral load and maintain this suppression as long as possible. However, for most patients treated with such potent regimen, several problems can limit their long term effectiveness and contribute to incomplete viral suppression. These problems include poor tolerability, metabolic toxic effects. In order to avoid common problems as toxicity it might be interested to simplify treatment with fewer toxicity, lower pill burden. In this study we will evaluate the safety and efficacy of a simplification treatment with TRIZIVIR in long term after a Boosted PI or NNRTI containing regimen as first line therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: TRIZIVIR Drug: Non-nucleoside reverse transcriptase inhibitor Drug: Boosted Protease Inhibitor |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized, Open Label Study to Compare the Safety and Efficacy of a Long Term Maintenance With TRIZIVIR After a Switch From a Boosted PI or a NNRTI as First Line Therapy for 96 Weeks. |
| Estimated Enrollment: | 152 |
| Study Start Date: | October 2004 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations| France | |
| GSK Clinical Trials Call Center | |
| Angers, France, 49000 | |
| GSK Clinical Trials Call Center | |
| Bobigny, France, 93000 | |
| GSK Clinical Trials Call Center | |
| Bondy, France, 93140 | |
| GSK Clinical Trials Call Center | |
| Bordeaux, France, 33075 | |
| GSK Clinical Trials Call Center | |
| Brest, France, 29200 | |
| GSK Clinical Trials Call Center | |
| Clamart, France, 92140 | |
| GSK Clinical Trials Call Center | |
| Garches, France, 92380 | |
| GSK Clinical Trials Call Center | |
| Gonesse, France, 95503 | |
| GSK Clinical Trials Call Center | |
| La Roche sur Yon, France, 85025 | |
| GSK Clinical Trials Call Center | |
| La Rochelle, France, 17000 | |
| GSK Clinical Trials Call Center | |
| Lyon, France, 69288 | |
| GSK Clinical Trials Call Center | |
| Marseille, France, 13006 | |
| GSK Clinical Trials Call Center | |
| Nice, France, 06202 | |
| GSK Clinical Trials Call Center | |
| Orleans, France, 45102 | |
| GSK Clinical Trials Call Center | |
| Paris, France, 75012 | |
| GSK Clinical Trials Call Center | |
| Paris, France, 75013 | |
| GSK Clinical Trials Call Center | |
| Suresnes, France, 92150 | |
| GSK Clinical Trials Call Center | |
| Toulon, France, 83056 | |
| GSK Clinical Trials Call Center | |
| Toulouse, France, 31052 | |
| GSK Clinical Trials Call Center | |
| Toulouse, France, 31059 | |
| GSK Clinical Trials Call Center | |
| Vandoeuvre, France, 54511 | |
| GSK Clinical Trials Call Center | |
| Villeneuve Saint Georges, France, 94190 | |
| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
| ClinicalTrials.gov Identifier: | NCT00449436 History of Changes |
| Other Study ID Numbers: | 101957, AZLF30008 |
| Study First Received: | March 19, 2007 |
| Last Updated: | February 26, 2008 |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
HIV treatment experienced |
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Protease Inhibitors Reverse Transcriptase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |