NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
Sponsor: University Hospital, Tours
Conditions: HIV
Interventions: triple therapy, dual therapy
Countries: France
In the early 2000s, the "TRILEGE©" study was realized to determine if the reductive anti retroviral strategy from an initial triple therapy (based on a protease inhibitor as the third agent) towards a dual therapy of nucleoside analogs (in particular the association of "zidovudine +lamivudine") for patients infected by HIV and stabilized for at least 3 months at a threshold value of 400 copies/ml, would allow to obtain a well-controlled plasmatic viral load, with an aim to reduce the long-term side effects of the treatment. The afore mentioned study showed that the reductive anti retroviral strategy was a failure. No study has as yet to revaluate this strategy, in particular in the current context of antiretroviral treatments. Indeed, modern nucleoside inhibitors (Kivexa®, Truvada®) have extended half-lives as well as a superior intrinsic power as compared to treatments proposed in the initial "TRILEGE©" study. Furthermore, the better quality of current triple therapy (as compared to that used 10 years ago) has lead to substantial viral reservoir reduction. Currently, a small number of patients is being successfully treated in the long-term (viral load \< 20 copies/ml) using nucleoside analog dual therapy. The particular characteristics of these patients have yet to be thoroughly investigated. The patients concerned were all treated prematurely before ever passing below 200 lymphocytes T CD4/mm3. It occurred that all these patients presented a low viral reservoir as measured by HIV DNA quantification (\< 2,7 log copies/106 PBMC). Therefore, by targeting patients who have (1) a strong immune restoration, (2) a low HIV DNA value and (3) a very good observance, the investigators emit the hypothesis that, reductive anti retroviral strategy that would consist in changing from a conventional triple therapy towards a Nucleoside reverse-transcriptase inhibitors dual therapy, could allow for durable control of viral replication with the concomitant benefice of reduced antiretroviral side effects and cost.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * HIV-1 infected patient * Initial TT ARV started above (or equal to) 150 / mm3 LT CD4, and 18 months prior to inclusion in the study * Ongoing antiretroviral therapy combining tenofovir + emtricitabine + a 3rd agent (IP / r, IP, NNRTI, II, Inhibitors) with at least one undetectable viral load (CV \<50 copies / mL) after introduction of the latter treatment. * Patient in virological success: CV \<50 copies / mL for at least 12 months, including visit to selection. * Absence of previous therapeutic failure: no viral load ≥ 200 copies / mL (after 6 months of treatment) (Except in the case of a justified therapeutic interruption: travel, stock-out ...) and of obtaining success Virologic after introduction of treatment, without concept of genotypic resistance known to the ARVs used. * Cellular DNA-HIV \<2.7 log copies / 106 PBMC * Zenith RNA-HIV \<150,000 copies / ml (excluding viral load values during primary infection if it is documented) * No genotypic resistance to currently used and known ARVs * Patient who has given written informed consent * Affiliate or beneficiary of a social security scheme * Patient followed on an outpatient basis, age ≥ 18 years. Exclusion Criteria: * Non-compliant patient * Subject is pregnant, or lactating, or of childbearing potential and without contraception * Active opportunistic infections * Major overweight (BMI ≥ 40) * Severe renal pathology (creatinine clearance \< 30ml/min) * Cirrhosis or severe liver failure (factor V \< 50%) * Prognosis threatened within 6 months * Circumstances that may impair judgment or understanding of the information given to the patient * Malabsorption syndromes * The following laboratory criteria: * Serum ASAT,ALAT \> 5 x upper limit of normal (ULN) * Thrombocytopenia with platelet count \< 50.000/ml * Anemia with hemoglobin \< 8g/dl * Polynuclear neutrophil count \< 500/mm3
- Caen, France
- CHR d'ORLEANS, France
- Créteil, France
- La Rochelle, France
- Le Coudray, France
- Nancy, France
- Niort, France
- Paris, France
- Paris, France
- Paris, France
- Poitiers, France
- Rouen, France
- Saintes, France
- Suresnes, France
- Tourcoing, France
- Tours, France