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.
Sponsor:
Hoffmann-La Roche
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00100984
First received: January 7, 2005
Last updated: December 15, 2005
Last verified: December 2005
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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: | Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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
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, District of Columbia, United States, 20007 | |
| Washington, 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 | |
| St. 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
| ClinicalTrials.gov Identifier: | NCT00100984 History of Changes |
| Other Study ID Numbers: | ML18021 |
| Study First Received: | January 7, 2005 |
| Last Updated: | December 15, 2005 |
| Health Authority: | United States: Food and Drug Administration |
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 September 28, 2016