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
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ClinicalTrials.gov Identifier: NCT00100984 |
Recruitment Status
:
Terminated
(Insufficient enrollment)
First Posted
: January 10, 2005
Last Update Posted
: June 20, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infection | Drug: FUZEON [enfuvirtide] | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 8 participants |
Allocation: | Randomized |
Primary Purpose: | Treatment |
Actual Study Start Date : | July 21, 2004 |
Actual Primary Completion Date : | July 16, 2005 |
Actual Study Completion Date : | July 16, 2005 |


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:
- 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

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): NCT00100984
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 |
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00100984 History of Changes |
Other Study ID Numbers: |
ML18021 |
First Posted: | January 10, 2005 Key Record Dates |
Last Update Posted: | June 20, 2017 |
Last Verified: | December 2005 |
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 |