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| Sponsor: | Glaxo Wellcome |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002390 |
Purpose
The purpose of this study is to see if giving 1592U89 to HIV-infected patients is safe and effective in lowering viral load (level of HIV in the blood) and raising the level of CD4 cells (cells of the body that help fight infection).
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Abacavir sulfate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind |
| Official Title: | A Phase II Randomized, Blinded, Dose-Ranging Multicenter Study to Evaluate the Safety and Efficacy of Different Regimens of 1592U89 Monotherapy Upon Selected Immunological and Virological Markers of HIV-1 Infection in Antiretroviral Therapy-Naive Patients |
Patients are randomized to receive one of three doses of 1592U89. During this randomized dosing phase, if a patient meets one of the following criteria, he/she is offered open-label 1592U89 (300 mg) plus zidovudine (ZDV) plus lamivudine (3TC) (or other licensed antiretrovirals according to standard practice). Criteria are based on falling CD4 counts (return to baseline on two occasions at least 1 month apart), disease progression (defined as occurrence of a new AIDS-defining event according to CDC classification excluding CD4 counts less than 200 cells/mm3), or lack of virus suppression (defined as less than 0.7log10 reduction in viral load at Week 4 with a repeat value 1 week later, more than 5000 copies/ml HIV RNA at Weeks 12, 16, 20, or 24, or 5000 copies/ml or more anytime after Week 24).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Contacts and Locations| France | |
| Hopital de Purpan / CHU de Rangueil / Medecine Interue | |
| Toulouse Cedex, France | |
| Hopital de Purpan / Service du Professeur Auvergnat | |
| Toulouse Cedex, France | |
| Groupe Hospitalier Bichat-Claude Bernard | |
| Paris Cedex 18, France | |
| Group Hospier Pitie-Salpetriere / Maladies Infec et Trop | |
| Paris Cedex 13, France | |
| Germany | |
| Universitat Erlangen | |
| Erlangen, Germany | |
| Universitatsklinikurn Frankfurt | |
| Frankfurt, Germany | |
More Information
| Study ID Numbers: | 238H, CNAB2002 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002390 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Anti-Infective Agents Communicable Diseases RNA Virus Infections Sexually Transmitted Diseases, Viral Anti-HIV Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Infection Antiviral Agents |
Pharmacologic Actions Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors Virus Diseases Anti-Retroviral Agents HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Abacavir Retroviridae Infections Nucleic Acid Synthesis Inhibitors |