T-20 With Anti-HIV Combination Therapy for Patients With Prior Anti-HIV Drug Treatment and/or Drug Resistance to Each of the Three Classes of Approved Anti-HIV Drugs
This study has been completed.
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
The purpose of this study is to compare the change in viral load (amount of HIV in the blood) of patients who receive T-20 with selected anti-HIV drugs to that of patients who receive only selected anti-HIV drugs.
||Intervention Model: Parallel Assignment
Primary Purpose: Treatment
||A Phase III Open-Label, Randomized, Active-Controlled Study Assessing the Efficacy and Safety of T-20 (HIV-1 Fusion Inhibitor) in Combination With an Optimized Background Regimen, Versus Optimized Background Therapy Alone, in Patients With Prior Experience and/or Prior Documented Resistance to Each of the Three Classes of Approved Antiretrovirals (Nucleoside Reverse Transcriptase, Non-Nucleoside Reverse Transcriptase and Protease Inhibitors)
| Estimated Enrollment:
Eligible patients remain on their pre-study regimen until baseline. An OB regimen is chosen by the physician and patient based on the patient's prior treatment history, prior and current laboratory abnormalities, the screening GT/PT antiretroviral resistance testing, and any prior GT/PT antiretroviral resistance (if available). The drugs in the OB regimen are chosen from among the currently approved antiretrovirals and permitted newly approved/investigational antiretrovirals available in the countries where the study is implemented, and must consist of 3 to 5 drugs, including no more than 1 newly approved/investigational agent. Patients are stratified with respect to viral load and use (versus non-use) of any of the allowed newly approved/investigational antiretrovirals. Patients are randomized to receive 1 of the following 2 treatments for 48 weeks: OB or OB plus T-20. Patients are followed to assess viral load, safety, antiretroviral resistance, T-20 pharmacokinetics, and quality of life. At the end of 48 weeks of treatment patients are allowed to (a) roll over and receive OB plus T-20 (for patients receiving OB regimen alone) or (b) continue taking OB plus T-20 (for patients already receiving OB plus T-20), for 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 in this study for a maximum of 100 weeks from their initial baseline visit date.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:
||16 Years and older (Child, Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
Patients may be eligible for this study if they:
- Are HIV-infected.
- Are at least 16 years old (have consent of parent or guardian if under 18).
- Have a viral load (level of HIV in the blood) of 5,000 copies/ml or more.
- Have received anti-HIV drugs for at least 6 months and/or have shown resistance to each of the 3 types of anti-HIV drugs as follows: nucleoside reverse transcriptase inhibitors (resistant to 1 or more); nonnucleoside reverse transcriptase inhibitors (resistant to 1 or more); and protease inhibitors (resistant to 2 or more, taken either together or 1 after the other for at least 6 months total).
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00008528
Lalezari JP, Henry K, O'Hearn M, Montaner JS, Piliero PJ, Trottier B, Walmsley S, Cohen C, Kuritzkes DR, Eron JJ Jr, Chung J, DeMasi R, Donatacci L, Drobnes C, Delehanty J, Salgo M; TORO 1 Study Group. Enfuvirtide, an HIV-1 fusion inhibitor, for drug-resistant HIV infection in North and South America. N Engl J Med. 2003 May 29;348(22):2175-85. Epub 2003 Mar 13. Erratum in: N Engl J Med. 2003 Sep 11;349(11):1100.
History of Changes
|Other Study ID Numbers:
||January 12, 2001
||August 31, 2001
|Last Update Posted:
||December 9, 2005
Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
Drug Resistance, Microbial
Additional relevant MeSH terms:
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
HIV Fusion Inhibitors
Viral Fusion Protein Inhibitors
Molecular Mechanisms of Pharmacological Action