The Safety and Effectiveness of 1592U89 Plus 141W94 Plus DMP 266 in Patients With HIV Who Developed a Resistance to Protease Inhibitors
- Conditions
- HIV Infections
- Registration Number
- NCT00002213
- Lead Sponsor
- Glaxo Wellcome
- Brief Summary
The purpose of this study is to see if it is safe and effective to give 1592U89 plus 141W94 plus DMP 266 to patients with HIV who have developed resistance to indinavir, ritonavir, saquinavir, or nelfinavir after at least 20 weeks of protease inhibitor treatment. This study also examines how long this combination therapy is effective before patients develop resistance to it.
- Detailed Description
This is a multicenter, open-label study. A total of 80 patients are treated on this study and include:
At least 30 patients with a viral burden of 500 - 40,000 copies/ml. At least 30 patients with a viral burden greater than 40,000 copies/ml. At least 20 patients with less than 1 year total prior treatment with nucleoside reverse transcriptase inhibitors (NRTIs).
All patients receive self-administered, combination antiretroviral therapy for 48 weeks, as follows:
1592U89 plus 141W94 plus DMP 266.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
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 (9)
Niaid / Nih
🇺🇸Bethesda, Maryland, United States
Northwestern Univ Med School AIDS Treatment Unit
🇺🇸Chicago, Illinois, United States
Univ Int Med Assoc Inc / Holmes Hosp / U of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Saint Vincents Hosp / AIDS Ctr / 4th Floor
🇺🇸New York, New York, United States
Beth Israel Deaconess Med Ctr
🇺🇸Boston, Massachusetts, United States
Kraus Med Partners
🇺🇸Los Angeles, California, United States
The Miriam Hosp
🇺🇸Providence, Rhode Island, United States
East Bay AIDS Ctr
🇺🇸Berkeley, California, United States
Univ of North Carolina Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States