DRUG
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
Status
Terminated
Phase
Phase 4
Enrollment
8
Locations
20
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Jan 10, 2005
Study start
Jul 21, 2004
Primary completion
Jul 16, 2005
Study completion
Jul 16, 2005
Results posted
Not reported
Registry updated
Jun 20, 2017
Outcomes
What the study measures.
Primary outcomes
Not reported in the indexed record.
Secondary outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- 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
Study locations
20 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Facility not named
Hobson City, Alabama, United States
Facility not named
Los Angeles, California, United States
Facility not named
Los Angeles, California, United States
Facility not named
Washington D.C., District of Columbia, United States
Facility not named
Washington D.C., District of Columbia, United States
Facility not named
Orlando, Florida, United States
Facility not named
Atlanta, Georgia, United States
Facility not named
Macon, Georgia, United States
Facility not named
Chicago, Illinois, United States
Facility not named
Chicago, Illinois, United States
Facility not named
Baltimore, Maryland, United States
Facility not named
Boston, Massachusetts, United States
Facility not named
Jackson, Mississippi, United States
Facility not named
St Louis, Missouri, United States
Facility not named
Newark, New Jersey, United States
Facility not named
New York, New York, United States
Facility not named
New York, New York, United States
Facility not named
Huntersville, North Carolina, United States
Facility not named
Dallas, Texas, United States
Facility not named
Houston, Texas, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Enfuvirtide.
NCT IDStudyPhase / statusEnrollmentUpdated
Intensification With Enfuvirtide in Naive HIV-infected Patients (ANRS130)
French National Agency for Research on AIDS and Viral Hepatitis · HIV Infections · AIDS
Phase 3
Completed
195
2026-04
Efficacy and Tolerance of the Switch From Enfuvirtine to Raltegravir in Antiretroviral Therapy Regimen in HIV Patients With Undetectable Viral Load
French National Agency for Research on AIDS and Viral Hepatitis · HIV Infections
Phase 3
Completed
170
2026-04
Raltegravir in Patients With End Stage Liver Disease and in Transplant Recipients
ANRS, Emerging Infectious Diseases · HIV Infection · Liver Failure
Phase 1 / Phase 2
Completed
14
2026-04
Early Intensification of Antiretroviral Therapy Including Enfuvirtide in HIV-1-Related Progressive Multifocal Leucoencephalopathy (ANRS125)
French National Agency for Research on AIDS and Viral Hepatitis · Leukoencephalopathy, Progressive Multifocal · HIV Infections
Phase 2
Completed
30
2026-04
Trial to Evaluate the Interest of a Reductive Anti Retroviral Strategy Using Dual Therapy Inspite of Triple Therapy
University Hospital, Tours · HIV
Phase 3
Completed
224
2025-12
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen
Gilead Sciences · HIV-1-infection
Phase 2 / Phase 3
Active, not recruiting
689
2025-10
Optimized Antiretroviral Therapy During Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Individuals
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · HIV
Early Phase 1
Completed
11
2021-11
Optimizing Treatment for Treatment-Experienced, HIV-Infected People
National Institute of Allergy and Infectious Diseases (NIAID) · HIV Infections
Phase 3
Completed
517
2021-11
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.