A 48 Week Study Comparing Treatment With Saquinavir + Lopinavir/Ritonavir in Combination With Enfuvirtide HAART Versus Saquinavir + Lopinavir/Ritonavir + Other Nucleoside Combinations to See the Efficacy of These Treatments in Patients Infected With HIV-1

This study has been terminated.

(Insufficient enrollment)

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT00100984

First received: January 7, 2005

Last updated: June 19, 2017

Last verified: December 2005

History of Changes

Purpose

The main objective of this study is to compare the safety and efficacy of an enfuvirtide containing regimen to a nucleoside combination regimen. Resistance information will also be collected.

Condition	Intervention	Phase
HIV Infection	Drug: FUZEON [enfuvirtide]	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Enfuvirtide

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:


Enrollment:	8
Actual Study Start Date:	July 21, 2004
Study Completion Date:	July 16, 2005
Primary Completion Date:	July 16, 2005 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

CD4 cell count greater than 50 cells/mm^3
HIV-1 RNA viral load greater than or equal to 5000 copies/mL
Patients must be HIV treatment experienced
Patients diagnosed with HIV-1 infection

Exclusion Criteria:

Female patients must not be able to have children or must be under effective contraceptives
Female patients who are pregnant
Have taken enfuvirtide and/or T-1249 before
Have serious kidney problems
Alcohol and/or drug abuse
Have had an organ transplant

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00100984

Locations


United States, Alabama

Hobson City, Alabama, United States, 36201
United States, California

Los Angeles, California, United States, 90033

Los Angeles, California, United States, 90036
United States, District of Columbia

Washington, D.C., District of Columbia, United States, 20007

Washington, D.C., District of Columbia, United States, 20009
United States, Florida

Orlando, Florida, United States, 32803
United States, Georgia

Atlanta, Georgia, United States, 30308

Macon, Georgia, United States, 31201
United States, Illinois

Chicago, Illinois, United States, 60612

Chicago, Illinois, United States, 60657
United States, Maryland

Baltimore, Maryland, United States, 21201
United States, Massachusetts

Boston, Massachusetts, United States, 02215-3318
United States, Mississippi

Jackson, Mississippi, United States, 39216-4505
United States, Missouri

Saint Louis, Missouri, United States, 63139
United States, New Jersey

Newark, New Jersey, United States, 07103
United States, New York

New York, New York, United States, 10011

New York, New York, United States, 10016
United States, North Carolina

Huntersville, North Carolina, United States, 28078
United States, Texas

Dallas, Texas, United States, 75246

Houston, Texas, United States, 77004

Sponsors and Collaborators

Hoffmann-La Roche

More Information


Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00100984 History of Changes
Other Study ID Numbers:	ML18021
Study First Received:	January 7, 2005
Last Updated:	June 19, 2017

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 Lopinavir Saquinavir Enfuvirtide	HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors HIV Fusion Inhibitors Viral Fusion Protein Inhibitors

ClinicalTrials.gov processed this record on August 18, 2017

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