ESP Study: A Study to Assess the Effect of Adding Fuzeon (Enfuvirtide) to an Antiretroviral Regimen in Fuzeon-Naive Patients With Sustained HIV Viral Suppression.
![]() |
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: NCT00461266 |
Recruitment Status
:
Withdrawn
(Slow recruitment)
First Posted
: April 17, 2007
Last Update Posted
: August 24, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: enfuvirtide [Fuzeon] Drug: Antiretroviral therapy | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Open Label Study to Determine the Immunological Benefits of Adding Fuzeon to an Antiretroviral Regimen in HIV-infected Fuzeon-naïve Patients With Sustained HIV Viral Suppression |
Study Start Date : | April 2007 |
Actual Primary Completion Date : | January 2008 |
Actual Study Completion Date : | January 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Drug: enfuvirtide [Fuzeon]
90mg sc bid
Drug: Antiretroviral therapy
As prescribed
|
Active Comparator: 2 |
Drug: Antiretroviral therapy
As prescribed
|
- Mean change in CD4 cell count from baseline [ Time Frame: Week 24 ]
- Change in HIV RNA from baseline [ Time Frame: Week 24 ]
- Change in HIV RNA and CD4 cell count [ Time Frame: Weeks 24-48 ]
- Correlation between CD4 count and HIV RNA; OIs; QoL; ADEs; SAEs. [ Time Frame: Throughout study ]

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: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- adult patients, >=18 years of age;
- documented chronic HIV infection;
- currently receiving a stable antiretroviral regimen;
- CD4 cell count <250 cells/mm3;
- HIV RNA viral load <400 copies/mL for >12 months.
Exclusion Criteria:
- prior exposure to Fuzeon;
- prior non-adherence to antiretroviral treatment regimens;
- active opportunistic infection;
- currently taking, or anticipated to take during the study, any immunomodulator.

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): NCT00461266
Australia | |
Carlton, Australia | |
Darlinghurst, Australia | |
Melbourne, Australia | |
Miami, Australia | |
Perth, Australia | |
South Yarra, Australia | |
Sydney, Australia |
Study Director: | Clinical Trials | Hoffmann-La Roche |
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00461266 History of Changes |
Other Study ID Numbers: |
ML19355 |
First Posted: | April 17, 2007 Key Record Dates |
Last Update Posted: | August 24, 2016 |
Last Verified: | August 2016 |
Keywords provided by Hoffmann-La Roche:
Treatment Experienced |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted 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 |