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 |
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