DRUG
enfuvirtide
1ml BID
Status
Completed
Phase
Not applicable
Enrollment
18
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
In order to better understand the source(s) and the mechanism(s) of HIV persistence and to potentially lead to further suppression of HIV from viral reservoirs, we propose to examine the effect of co-administration of enfuvirtide, an entry inhibitor of HIV, on diminution of the size of the viral reservoir in infected individuals who are receiving effective antiviral therapy for extended periods of time (\> 5 years).
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Jun 6, 2006
Study start
Feb 2006
Primary completion
Jul 2007
Study completion
Jan 2010
Results posted
Not reported
Registry updated
Jun 5, 2012
Outcomes
What the study measures.
Primary outcomes
The change of proviral HIV-1 DNA in both purified resting and activated CD4 T cells from baseline to month 6.
Time frame · 6 months
The change of proviral HIV-1 DNA in both purified resting and activated CD4 T cells from baseline to month 6.
Secondary outcomes
To determine the change of proviral HIV-1 DNA from baseline to month 3
Time frame · 3 months
To determine the change of proviral HIV-1 DNA from baseline to month 3
To determine the change of proviral HIV-1 DNA from months 6 to 9 after the enfurvitide has been stopped for 3 months in the treatment arm
Time frame · 9 months
To determine the change of proviral HIV-1 DNA from months 6 to 9 after the enfurvitide has been stopped for 3 months in the treatment arm
To quantify plasma HIV (limit of detection 2 copies/ml of plasma)
Time frame · 9 months
To quantify plasma HIV (limit of detection 2 copies/ml of plasma)
To quantify cell associated HIV RNA (unspliced and multiply spliced) in resting and activated CD4+ T cells
Time frame · 9 months
To quantify cell associated HIV RNA (unspliced and multiply spliced) in resting and activated CD4+ T cells
To determine the decay characteristics of HIV in resting CD4+ T cells by quantitative co-culture assays
Time frame · 9 months
To determine the decay characteristics of HIV in resting CD4+ T cells by quantitative co-culture assays
To determine the half-life of HIV in resting CD4+ T cells
Time frame · 9months
To determine the half-life of HIV in resting CD4+ T cells
To carry out phylogenetic analysis of HIV in the plasma, resting, and activated CD4+ T cell compartments
Time frame · 9 months
To carry out phylogenetic analysis of HIV in the plasma, resting, and activated CD4+ T cell
To quantify the amount of HIV in gastrointestinal-associated lymphoid tissue (GALT) by quantitative co-culture assays (as part of a sub-study - see GALT sub-study)
Time frame · 9 months
To quantify the amount of HIV in gastrointestinal-associated lymphoid tissue (GALT) by quantitative co-culture assays (as part of a sub-study - see GALT sub-study)
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 60 Years
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: 1. Patient must be HIV infected 2. Patient must be \> 18 years old 3. Patient must be taking standard combination antiretroviral therapy with 2-3 NRTIs and 1-2 PIs or a NNRTIs for at least five years 4. Patient must have a viral load \< 50 copies/mL (using the standard available methods of detection) during the entire time on standard combination antiretroviral therapy except for initial fall of viral load 5. Patient must have a CD4 count above 400 cells/mm3 in last 3 months 6. Female patient must agree to use two methods of birth control or abstinence during the period of the study 7. Patient has to have signed full informed consent Exclusion Criteria: 1. Patient who would have difficulty participating in a trial due to non-adherence or substance abuse 2. Patient who have taken mono or dual antiretroviral therapy 3. Patient who have had a viral load \> 50 copies/mL on any antiretroviral regimen 4. Patient with any of the following abnormal laboratory test results in screening: * Hemaglobin \< 100 g/L * Neutrophil count \< 750 cells/uL * Platelet count \< 50,000 cells/L * AST or ALT \> 5X the upper limit of normal * Creatinine \> 250 umol/L 5. Patient with a malignancy 6. Patient with other significant underlying disease (non-HIV) that might impinge upon disease progression or death 7. Patient with an active AIDS-defining illnesses in the past six months 8. Patients who are pregnant
Study locations
1 registered sites.
Canada. Showing up to 24 locations stored in the fast local snapshot.
Maple Leaf Medical Clinic
Toronto, Ontario, Canada
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.