HIV-1 Infection Clinical Trial
Official title:
Management of Participants With Low-level Persistent Viremia (ANRS 161 L-VIR)
Management of participants with low-level persistent viremia
Status | Terminated |
Enrollment | 4 |
Est. completion date | September 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age = 18 years - HIV-1 infection - On combined antiretroviral regimen for at least 18 months - Participant with a stable antiretroviral regimen for at least 6 months, including 2 Reverse-transcriptase inhibitor (INTI) + 1 Boosted Protease Inhibitor IP/r , - participant with at least 2 consecutive viral load between 50 and 500 copies/milliliter over the last 9 months (with at least 2 months between the two measurements) quantified with the same commercial kit. - 50 <or= VL < 500 copies/milliliter at screening visit quantified with the same commercial kit than previous one. - Participant naïve to raltegravir (RAL) - failure of amplification or successful realization of genotypic resistance test without evidence for resistance mutations against current treatment (3TC/FTC accepted with M184V mutation) - creatinin < 3 Upper Limit normal (ULN) - Aspartate Amino Transférase (ASAT), Alanine Amino Transférase (ALAT) < 5 Upper Limit normal (ULN) - hemoglobin > 8 g/dL - platelets > 50 000/mm3 - In women, lack of current pregnancy verified by Beta Human Chorionic Gonadotropin (ßHCG) at week -4 visit and use of a mechanical contraceptive method - Informed consent - Participants with an active health insurance coverage (article L1121-11 du Code de la Santé Publique) Exclusion Criteria: - HIV-2 infection, - severe medical condition in the last month (inclusion is possible for a stable condition at screening) - breastfeeding women, current pregnancy or planned pregnancy within 12 months. - participant currently receiving Prezista® (darunavir)/ Norvir® (ritonavir) (600/100 mg) two times a day (BID) (of note, participants receiving Prezista® (darunavir)/ Norvir® (ritonavir) one time a day (QD) can be included) - Hypersensitivity Prezista® (darunavir)/ Norvir® (ritonavir) or to any of the excipients of the study treatment - participant under judicial protection (judicial protection due to temporarily and slightly diminished mental or physical faculties), or under legal guardianship - planned absence that could prevent the patient from participating in the trial (travel abroad, moving, pending work transfer ...) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Hôpital Avicenne | Bobigny | |
France | Hôpital Jean Verdier | Bondy | |
France | Hôpital Pellegrin | Bordeaux | |
France | Hôpital Saint André | Bordeaux | |
France | Hôpital de la côte de Nacre | Caen | |
France | Hôpital Henry Mondor | Creteil | |
France | Hôpital Européen Georges Pompidou | France | |
France | Hôpital de Bicêtre | le Kremlin Bicêtre | |
France | Hôpital de l'Hôtel Dieu | Nantes | |
France | Hôpital Bichat | Paris | |
France | Hôpital Cochin | Paris | |
France | Hôpital Hôtel Dieu | Paris | |
France | Hôpital Lariboisière | Paris | |
France | Hôpital Necker | Paris | |
France | Hôpital pitié Salpetrière | Paris | |
France | Hôpital Saint Louis | Paris | |
France | Hôpital Tenon | Paris | |
France | Hôpital Pontchaillou | Rennes | |
France | Hôpital Charles Nicoll | Rouen | |
France | Hôpital Purpan | Toulouse |
Lead Sponsor | Collaborator |
---|---|
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) | Janssen-Cilag Ltd. |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients in Virologic success by week 12 | A virologic success is defined by a patient having plasma HIV-1 RNA levels <50 copies/ml at weeks 8 and 12. | week 12 | Yes |
Secondary | Proportion of participants with HIV-1 RNA < 50 copies/ml | week 4, week 8, week 12, week 24, week 36, week 48 | No | |
Secondary | Proportion of participants with HIV-1 RNA < 20 copies/ml | week 4, week 8, week 12, week 24, week 36, week 48 | No | |
Secondary | Proportion of participants with HIV-1 RNA <1copy/ml | week 8, week 12, week 24, week 36, week 48 | No | |
Secondary | Change in CD4 cells count from baseline | •Change was calculated as the CD4 count at the corresponding week minus the baseline CD4 count | week 12, week 24, week 48 and end visit | No |
Secondary | Number of Participants With Virologic Failure and Emergence of Resistance | •resistance patterns at failure time compared with day 0, in HIV-DNA and in HIV-RNA | day 0 and visit at failure time | No |
Secondary | Quantification of HIV DNA in peripheral blood mononucleated cell (PBMC) | Quantification of HIV DNA in PBMC at day 0 and its association with the proportion of success in each arm | day 0 | No |
Secondary | Levels of antiretroviral drugs in plasma | •plasma concentrations of antiretroviral drugs and correlation with success or failure of the strategy | day 0 and end visit | No |
Secondary | Levels of antiretroviral drugs in hair | •measurement of concentrations of antiretroviral drugs treatments in hair | day 0, week 12, week 24and end visit | No |
Secondary | Levels of HIV-1 RNA in seminal plasma | quantification of HIV RNA in seminal plasma | day 0, week 12, week 48 and end visit | No |
Secondary | Incidence of Study interruption | •proportion of participants who discontinued the strategy assigned by randomization at day 0 because of failure | From day 0 to week 24 | No |
Secondary | Incidence of clinical and biological adverse events | • proportions of participants experiencing a clinical or biological adverse events (ANRS scale) | from day 0 to week 48 | No |
Secondary | Self-reported adherence | •self-reported percentage of antiretroviral treatment participant had taken during the last 4 weeks | day 0, week 4, week 8, week 12, week 24, week 36, week 48 and end visit | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03188523 -
Activity of MK-8504 in Anti-retroviral-naïve, Human Immunodeficiency Virus 1 (HIV-1) Infected Participants (MK-8504-002)
|
Phase 1 | |
Active, not recruiting |
NCT06185452 -
Implementation of Out-of-HOspital Administration of the Long-Acting Cabotegravir+Rilpivirine
|
Phase 4 | |
Recruiting |
NCT02881320 -
Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination in Adolescents and Children With Human Immunodeficiency Virus-1
|
Phase 2/Phase 3 | |
Completed |
NCT02542852 -
A Study of a Nucleoside Sparing Regimen in HIV-1 Infected Patients With Detectable Viremia
|
Phase 2 | |
Completed |
NCT02513771 -
Sitagliptin for Reducing Inflammation and Immune Activation
|
Phase 2 | |
Completed |
NCT02057796 -
Systematic Empirical vs. Test-guided Anti-TB Treatment Impact in Severely Immunosuppressed HIV-infected Adults Initiating ART With CD4 Cell Counts <100/mm3
|
Phase 4 | |
Terminated |
NCT02732457 -
Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Infected Patients
|
||
Completed |
NCT01989910 -
Compare the Efficacy and Safety of Raltegravir Versus Efavirenz Combination Therapy in Treatment-naïve HIV-1 Patients
|
Phase 4 | |
Completed |
NCT01627678 -
Immunotherapy With Vacc-C5 With Adjuvant GM-CSF or Alhydrogel in HIV-1-infected Subjects on ART
|
Phase 1/Phase 2 | |
Completed |
NCT01704781 -
Vacc-4x + Lenalidomide vs. Vacc-4x +Placebo in HIV-1-infected Subjects on Antiretroviral Therapy (ART)
|
Phase 1/Phase 2 | |
Completed |
NCT01466595 -
Rifaximin as a Modulator of Microbial Translocation and Immune Activation
|
Phase 2 | |
Completed |
NCT01348308 -
Immuno-stimulation With Maraviroc Combined to Antiretroviral Therapy in Advanced Late Diagnosed HIV-1 Infected Patients
|
Phase 3 | |
Completed |
NCT01403051 -
High Dose Vitamin D and Calcium for Bone Health in Individuals Initiating HAART
|
Phase 2 | |
Completed |
NCT01019551 -
Therapeutic Intensification Plus Immunomodulation in HIV-infected Patients
|
Phase 2 | |
Completed |
NCT01511809 -
Efficacy of Atazanavir/Ritonavir Monotherapy as Maintenance in Patients With Viral Suppression
|
Phase 3 | |
Terminated |
NCT01130376 -
Novel Interventions in HIV-1 Infection
|
Phase 1 | |
Completed |
NCT00323687 -
SONETT: Switch Study to Once Daily HIV Treatment Regimen With Truvada
|
Phase 4 | |
Completed |
NCT04003103 -
Safety and Pharmacokinetics of Oral Islatravir (MK-8591) Once Monthly in Participants at Low Risk of Human Immunodeficiency Virus 1 (HIV-1) Infection (MK-8591-016)
|
Phase 2 | |
Completed |
NCT02527096 -
A Trial Evaluating Maintenance Therapy With Lamivudine (Epivir®) and Dolutegravir (Tivicay®) in Human Immunodeficiency Virus 1 (HIV-1) Infected Patients Virologically Suppressed With Triple Highly Active Antiretroviral Therapy (HAART) (ANRS 167 Lamidol)
|
Phase 2 | |
Active, not recruiting |
NCT04776252 -
Open-label, Follow-up of Doravirine/Islatravir (DOR/ISL 100 mg/0.75mg) for Participants With Human Immunodeficiency Virus-1 (HIV-1) Infection (MK-8591A-033)
|
Phase 3 |