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
|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.|
|ClinicalTrials.gov Identifier: NCT00008528|
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Enfuvirtide||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||525 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||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)|
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, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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).
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
|Other Study ID Numbers:||
|First Posted:||August 31, 2001 Key Record Dates|
|Last Update Posted:||June 24, 2005|
|Last Verified:||June 2001|
Drug Therapy, Combination
Drug Resistance, Microbial
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
RNA Virus Infections
Immunologic Deficiency Syndromes
Immune System Diseases
HIV Fusion Inhibitors
Viral Fusion Protein Inhibitors
Molecular Mechanisms of Pharmacological Action