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Study of Protease Inhibitor Regimen Switch in HIV-1 Infected Patients With Undetectable Viral Load to Prove the Non-inferiority of Once Daily Dose Regimen Versus the Current Twice Daily Regimen to Maintain the Viral Load Under the Limit of Detection.

Information source: Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV-1 Infection; HIV Infections

Intervention: darunavir (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida

Official(s) and/or principal investigator(s):
Jade Ghosn, MD, Principal Investigator, Affiliation: Centre Hsopitalier Universitaire de Bicêtre
Christine Katlama, MD, Study Director, Affiliation: Groupe Hospitalier Pitié-Salpêtrière

Summary

Darunavir boosted with ritonavir (darunavir/r) is a powerful protease inhibitor, able to reduce the viral load in patients infected with multi-resistant HIV strains; In vitro and in vivo studies have shown that the induction of resistance mutations in the protease gene is much more difficult with the association darunavir/r compared to the other ritonavir-boosted protease inhibitors (PI/r), testifying of a significantly higher genetic barrier to resistance. Moreover, the tolerance to darunavir is good, and the pharmacologic profile of this molecule allows a once daily administration with a 800/100 mg dose in patients infected with a wild HIV strain or with a slightly resistant to darunavir/r strain. Thus, we propose to evaluate the efficacy of the darunavir/r association once daily as a substitute to a protease inhibitor regimen administered twice daily in patients with undetectable viral load receiving a tritherapy including a protease inhibitor administered twice daily.

Clinical Details

Official title: Non-comparative, Opened Study, Evaluating in HIV-1 Infected Patients With Undetectable Viral Load, Treated by an Antiretroviral Combination Including a Protease Inhibitor Boosted With Ritonavir and Administered by Oral Route Twice a Day, the Substitutability of the Current Protease Inhibitor Regimen by the Association Darunavir/Ritonavir 800/100 mg Once a Day to Maintain the Viral Load Under the 50 Copies/ml Limit of Detection After 24 Weeks of Treatment.

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Undetectable viral load ( < 50 copies/ml)

Secondary outcome:

Proportion of patients with undetectable viral load under 50 copies/ml

Proportion of patients in the situation of virologic failure defined as a viral load higher than 50 copies/ml confirmed with a second examen at least two weeks later.

CD4 lymphocytes count and evolution

Lipids balance evolution

Treatment tolerance

Measure of the darunavir/r concentrations variability and correlation with the potential adverse events and/or virologic failures.

Spermatic viral load (sub-study concerning 15 patients)

Pharmacologic sub-studies

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- HIV-1 infected patients

- Treatment with an association of 3 molecules including two Nucleotidic Reverse

Trasncriptase Inhibitors and a ritonavir-boosted protease inhibitor BID, unchanged for at least one month

- At least two documented undetectable viral loads (under 50 copies/ml) within the last

3 months

- Naiive from darunavir

- Free from any opportunistic infection

- Creatinin < 3N

- ASAT & ALAT < 5N

- Haemoglobin > 7 g/dl

- Platelets > 50 000/mm3

- Negative pregnancy test for women of childbearing potential and use of a mechanic

contraceptive during sexual relationships

- Signed informed consent

Exclusion Criteria:

- HIV-2 infected patients

- Treatment different from the association described in the inclusion criteria (2 NRTIs

+ 1 PI/r BID)

- Patients with a documented problem of treatment compliance within the last 12 months

- Ongoing active treatment against any opportunistic infection or tuberculosis

- Any critic concomitant condition (alcohol consumption, fatigue) that may jeopardize

treatment compliance and/olr tolerance, and interfere with the protocol compliance

- Any concomitant treatment that may potentialize or inhibit hepatic cyotchrome-based

enzymes

- Patient already treated with darunavir

- Patient treated with tipranavir, enfuvirtide, raltegravir, etravirine, and/or

maraviroc

Locations and Contacts

Centre Hospitalier Universitaire de Bicêtre - Service de Médecine Interne et Maladies Tropicales, Le Kremlin Bicêtre 94275, France

Groupe Hospitalier Pitié-Salpêtrière - Service de Médecine Interne, Paris 75013, France

Groupe Hospitalier Pitié-Salpêtrière - Service des Maladies Infectieuses et Tropicales, Paris 75013, France

Hôpital Necker Enfants Malades - Service des Maladies Infectieuses et Tropicales, Paris 75015, France

Hôpital Tenon - Service des Maladies Infectieuses et Tropicales, Paris 75020, France

Additional Information

Starting date: May 2009
Last updated: January 21, 2014

Page last updated: August 23, 2015

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