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
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| ClinicalTrials.gov Identifier: NCT00008528 |
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Recruitment Status :
Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
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Sponsor:
Hoffmann-La Roche
Collaborator:
Trimeris
Information provided by:
NIH AIDS Clinical Trials Information Service
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections | Drug: Enfuvirtide | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 525 participants |
| Intervention Model: | Parallel Assignment |
| Primary Purpose: | Treatment |
| 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) |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Enfuvirtide
Information from the National Library of Medicine
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| Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria
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
Locations
Show 37 study locations
Sponsors and Collaborators
Hoffmann-La Roche
Trimeris
Publications:
| ClinicalTrials.gov Identifier: | NCT00008528 |
| Other Study ID Numbers: |
295C T20-301 |
| First Posted: | August 31, 2001 Key Record Dates |
| Last Update Posted: | June 24, 2005 |
| Last Verified: | June 2001 |
Keywords provided by NIH AIDS Clinical Trials Information Service:
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HIV-1 Drug Therapy, Combination Drug Resistance, Microbial RNA, Viral |
Membrane Fusion Anti-HIV Agents Viral Load |
Additional relevant MeSH terms:
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HIV Infections Blood-Borne Infections Communicable Diseases Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Immunologic Deficiency Syndromes Immune System Diseases Enfuvirtide HIV Fusion Inhibitors Viral Fusion Protein Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |