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Home > "T" Clinical Trials Conditions > T-20 in HIV Patients with Prior Drug Treatment and/or Resistance to Each of the Three Classes of Anti-HIV Drugs  T-20 in HIV Patients with Prior Drug Treatment and/or Resistance to Each of the Three Classes of Anti-HIV Drugs
T-20 in HIV Patients with Prior Drug Treatment and/or Resistance to Each of the Three Classes of Anti-HIV Drugs
For Condition: HIV Infections
Status: Completed
Sponsor(s): Hoffmann-La Roche , Trimeris
Synopsis: The purpose of this study is to show if a dose of T-20 added to an anti-HIV combination (chosen specifically for each patient) lowers viral load by at least a certain level after 24 weeks as compared to an anti-HIV combination (chosen specifically for each patient) alone. Another purpose is to show if the patient response to T-20 will be maintained for 48 weeks.
Details: An OB regimen is selected to be initiated at baseline by the physician and patient. The OB regimen is based on the patient's prior treatment history as well as the results from the first screening visit HIV-1 genotypic and phenotypic (GT and PT) resistance testing and prior GT/PT antiretroviral resistance testing (if available). Prior or current laboratory abnormalities, including triglycerides and cholesterol, should also be taken into account when selecting the OB regimen. Patients are stratified with respect to the following: 1) screening viral load (less than 40,000 or 40,000 or more copies/ml); and 2) number of allowed investigational antiretrovirals (0, 1, or 2). Patients then are randomized to receive 1 of the following treatments for 48 weeks: OB regimen or OB plus T-20 regimen. Patients are seen for evaluation of efficacy and safety at Weeks 1, 2, and 4, every 4 weeks through Week 24, and then every 8 weeks through Week 48. In addition, efficacy only is evaluated at Weeks 6, 10, and 14. Patients also may be seen at additional visits during the study for plasma HIV-1 RNA measurements to potentially confirm virological failure. Patients initially randomized to the OB arm who meet the criteria for virological failure and who switch to OB plus T-20 after Week 8 are followed under a new ("switch") schedule of assessments. Patients are encouraged to change their OB regimen at the time of switch. Patients initially randomized to the OB plus T-20 arm who meet the criteria for virological failure may continue to receive OB plus T-20 if the patient and the physician feel that there is sufficient benefit. Patients are encouraged to change their OB regimen after Week 8 if they choose to continue on OB plus T-20 despite meeting the criteria for virological failure. Patients on OB or OB plus T-20 arm who meet the criteria for virological failure but who do not wish to either switch to T-20 (for patients initially randomized to OB arm) or continue with T-20 (for patients initially randomized to OB plus T-20) are allowed to remain in the study for a maximum of 1 month. At the end of the 48 weeks of treatment, patients are allowed to participate in 1 of the following treatment extensions: a) roll-over and receive OB plus T-20 (for patients receiving OB alone); or b) continue taking OB plus T-20 (for patients already receiving OB plus T-20), for a maximum of an additional 48 weeks (plus 4 weeks safety follow-up period), or until 12 weeks after commercial availability of T-20 in the country in which they are treated, whichever comes first. All patients are followed for a maximum of 100 weeks from their initial baseline visit date.
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are HIV infected. - Are at least 16 years of age. - Have an HIV-1 RNA of at least 5,000 copies/ml. - Have received anti-HIV drugs for at least 3 months and/or have written records of resistance to at least 1 member of each of the 3 classes of anti-HIV drugs (nucleoside reverse transcriptase inhibitors [NRTIs], nonnucleoside reverse transcriptase inhibitors [NNRTIs], and protease inhibitors [PIs]). Resistance to NNRTIs may not be required in certain cases.
Total Enrollment: 525
Location and Contact Information:
Rheinische Friedrich Wilhelms Universitaet Medizinische
Bonn, ,
Germany
Ospedale Amedeo di Savoia
Torino, ,
Italy
Royal Brisbane Hosp
HERSTON, ,
Australia
Clinica Malattie Infettive
Milano, ,
Italy
Alfred Hosp
Prahan, ,
Australia
Hospital General Universitario
Valencia, ,
Spain
Brighton Gen Hosp
Brighton, ,
United Kingdom
North Manchester Gen Hosp
Manchester, ,
United Kingdom
Taylors Square Clinic
Sydney, ,
Australia
Saint Vincent's Hosp
Darlinghurst, ,
Australia
Prahran Market Clinic
South Yarra, ,
Australia
Hospital Germans Trias I Pujol
Barcelona, ,
Spain
Univ College London Med School
London, ,
United Kingdom
CHU Saint Pierre
Brussels, ,
Belgium
Hopital cantonal / Div des maladies infectieuses
Geneve, ,
Switzerland
Univ Hosp Basel / Med Outpatient Dept
Basel, ,
Switzerland
Klinikum Der Johann Wolfgang Goethe Universitat
Frankfurt, ,
Germany
UO Malattie Infettive
Firenze, ,
Italy
Inst of Tropical Medicine
Antwerpe, ,
Belgium
Allgemeines Krankenhaus St Georg
Hamburg, ,
Germany
Karolinska Hospital
Stockholm, ,
Sweden
Hosp La Paz
Madrid, ,
Spain
Royal Liverpool Univ Hosp
Liverpool, ,
United Kingdom
Universitatsspital Zurich
Zurich, ,
Switzerland
UZ Gasthuisberg
Leuven, ,
Belgium
Univ Medical Center Utrecht
CX Utrecht, ,
Netherlands
King's College Hospital
London, ,
United Kingdom
University Hospital Mas
Malmoe, ,
Sweden
Chelsea and Westminster Hosp
London, ,
United Kingdom
Natac Med Centre
Amsterdam, ,
Netherlands
CHUV
Lausanne, ,
Switzerland
Universitatskrankenhaus Eppendorf
Hamburg, ,
Germany
Western Gen Hosp
Edinburgh, ,
United Kingdom
Holdsworth House General Practice
Darlinghurst, ,
Australia
Venhalsan Soder Hosp
Stockholm, ,
Sweden
Carlton Clinic
Carlton, ,
Australia
Royal Free Hosp
London, ,
United Kingdom
Additional Information:
Study ID Numbers: 295D; T20-302
Study Start Date:
Record last reviewed: May 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00021554
Other Hiv Infections Studies:
1. Roll-over Trial Only for HIV-1 Infected Subjects in Control Groups of Selected TMC114 Trials who Fail Treatment
2. The Safety and Effectiveness of Adefovir Dipivoxil in HIV-Infected Children
3. The Safety and Effectiveness of SPC3 in HIV-1 Infected Patients
4. The Healthy Life Choices Project in HIV-Positive Patients
5. Treatment of Psoriasis Using Acitretin in HIV-Positive Patients
Related Studies:
Other HIV Infections Clinical Trials
Other Clinical Trials
Other Brussels Clinical Trials
T-20 in HIV Patients with Prior Drug Treatment and/or Resistance to Each of the Three Classes of Anti-HIV Drugs
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