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Completed

NCT Number: NCT00849160

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.

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.

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Key information

Conditions

HIV-1 Infection Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Darunavir

Drug

darunavir/r 800/100 mg once daily by oral route, 48 weeks of treatment

Primary outcomes

  1. Undetectable viral load ( < 50 copies/ml)

    Time frame: Week 24

Secondary outcomes

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

    Time frame: All visits

  2. 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.

    Time frame: All visits

  3. CD4 lymphocytes count and evolution

    Time frame: All visits

  4. Lipids balance evolution

    Time frame: All visits

  5. Treatment tolerance

    Time frame: All visits

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

    Time frame: All visits

  7. Spermatic viral load (sub-study concerning 15 patients)

    Time frame: Day 0 and Week 48

  8. Pharmacologic sub-studies

    Time frame: All visits

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study 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.

Acronym: RADAR

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Feb 23, 2009
Registry last updated
Jan 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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