A Study of the Safety and Effectiveness of Different Doses of 1592U89 in HIV-Infected Patients
- Conditions
- HIV Infections
- Registration Number
- NCT00002390
- Lead Sponsor
- Glaxo Wellcome
- Brief Summary
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).
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Not specified
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Universitatsklinikurn Frankfurt
🇩🇪Frankfurt, Germany
Group Hospier Pitie-Salpetriere / Maladies Infec et Trop
🇫🇷Paris Cedex 13, France
Universitat Erlangen
🇩🇪Erlangen, Germany
Groupe Hospitalier Bichat-Claude Bernard
🇫🇷Paris Cedex 18, France
Hopital de Purpan / Service du Professeur Auvergnat
🇫🇷Toulouse Cedex, France
Hopital de Purpan / CHU de Rangueil / Medecine Interue
🇫🇷Toulouse Cedex, France