Switch From Nevirapine-based Regimen to Once a Day Rilpivirine/Emtricitabine/Tenofovir (Near- Rwanda)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by Stanford University
Sponsor:
Collaborators:
Rwanda Biomedical Center
Gilead Sciences
Information provided by (Responsible Party):
Andrew Zolopa, Stanford University
ClinicalTrials.gov Identifier:
NCT02104700
First received: April 1, 2014
Last updated: NA
Last verified: April 2014
History: No changes posted
  Purpose

The study will be an open-label, pilot study in virologically suppressed patients comparing the efficacy, safety and tolerability of two Antiretroviral regimen strategies:

Arm A: "Immediate switch" Rilpivirine/Emtricitabine/Tenofovir (single tablet formulation (STF))at randomization

Arm B: "Delayed switch" Continue Nevirapine/Lamivudine/other Nucleoside reverse transcriptase inhibitor (NRTI)through 24 weeks then switch to STF of Rilpivirine/emtrictabine/tenofovir and followed through 48 weeks.


Condition Intervention Phase
HIV
Drug: Rilpivirine/Emtricitabine/Tenofovir
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Switch From Nevirapine-based Regimen to Once a Day Rilpivirine/Emtricitabine/Tenofovir in Virologically-suppressed HIV-infected Rwandans (Near-Rwanda)"

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Explore Efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    To compare proportion of subjects successfully maintaining a plasma viral load <200 copies /mL at week 24 in subjects randomized to rilpivirine/emtricitabine/tenofovir vs. in those randomized to initially continue nevirapine-based ART in this pilot study.


Secondary Outcome Measures:
  • HIV RNA levels [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    To compare between arms the probability of having an HIV RNA level <50 and <400 copies/mL at 24 weeks


Estimated Enrollment: 150
Study Start Date: April 2014
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Rilpivirine/Emtricitabine/Tenofovir
"Immediate switch": RILPIVIRINE/ EMTRICITABINE /TENOFOVIR FDC QDAY at randomization.
Drug: Rilpivirine/Emtricitabine/Tenofovir
Rilpivirine 25mg/Emtricitiabine 200mg/Tenofovir 300mg FDC qday
Other Name: Complera
Active Comparator: Nevirapine/Lamivudine/ plus other NNRTI
"Delayed switch": Continue NEVIRAPINE 200MG BID + LAMIVUDINE 300MG + OTHER NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR (NRTI) through 24 weeks then switch to RILPIVIRINE 25MG/ EMTRICITABINE 200MG/TENOFOVIR 300MG FDC QDAY and then follow through 48 weeks.
Drug: Rilpivirine/Emtricitabine/Tenofovir
Rilpivirine 25mg/Emtricitiabine 200mg/Tenofovir 300mg FDC qday
Other Name: Complera

Detailed Description:

The current study is designed to be the first study to compare a continued nevirapine-based regimen to a switch to the FDC of rilpivirine/emtricitabine/tenofovir. Rwanda is a model country for implementation of newer approaches to more innovative ART strategies with an excellent National HIV Treatment program in place but has limited experience with clinical trials and as with most African countries has no clinical experience with Rilpivirine in treating HIV infected adults.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry. A second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test or a previous detectable HIV RNA level
  • HIV RNA level below the limit of quantification of the viral load assay in use in-country within the last 12 months
  • Screening HIV RNA level below the limit of quantification as defined by the local assay
  • At least twelve months of stable first-line antiretroviral therapy consisting of nevirapine and 2 nRTIs approved by the Rwandan HIV Treatment guidelines. (No prior changes in ART are allowed)
  • Enrolled in the Rwanda National ART Program with no in-country transfer within the program.
  • Negative TB symptom screen or eligible based on algorithm outlined in
  • Laboratory values obtained within 30 days prior to study entry:

    • Hemoglobin greater than 8.0 g/dL
    • Platelet count greater than 40,000/mm3
    • AST (SGOT), ALT (SGPT), and alkaline phosphatase less than 5 X ULN
    • Total bilirubin less than 2.5 x ULN
    • Calculated creatinine clearance greater than 60 mL/min as estimated by the Cockcroft-Gault equation:

      • Ability to meet the nutritional requirements for rilpivirine; largest meal should consist of at least 400 total kcals and 117 kcals of fat (13 grams) to be assessed at screening.
      • For women of reproductive potential, negative serum or urine pregnancy test within 4 weeks of initiating study medications and a negative urine pregnancy test at the entry visit prior to randomization.
  • "Women of reproductive potential" is defined as women who have not been post-menopausal for at least 24 consecutive months (i.e., who have had menses within the preceding 24 months) and have not undergone surgical sterilization (e.g., hysterectomy, bilateral oophorectomy, or tubal ligation).
  • Age greater than18 years.
  • Ability and willingness of subject to give informed consent.

Exclusion Criteria:

  • History of on-treatment virologic failure (defined as HIV RNA level greater than 200 copies/mL at or after 6 months of antiretroviral therapy)
  • Any change in prior ART.
  • Currently breastfeeding.
  • Active tuberculosis.
  • Serious illness requiring systemic treatment and/or hospitalization until candidate either completes therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least 14 days prior to study entry.
  • NOTE: Isolated cutaneous Kaposi's Sarcoma, oral candidiasis, vaginal candidiasis, mucocutaneous herpes simplex, and other non-serious illnesses (as judged by the site investigator) have no restriction.
  • Known allergy/sensitivity to study drugs or their formulations.
  • Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  • Requirement for any current medications that are prohibited with any study treatment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02104700

Locations
Rwanda
Rwanda Military Hospital Not yet recruiting
Kinombe, Rwanda
Contact: Eric Seruyange, MD       serayange@yahoo.fr   
Contact: Francois Uwinkindi, MD       uwifranco@gmail.com   
Sub-Investigator: Sabin Nsanzamana, MD         
Sub-Investigator: Eric Seruyange, MD         
Sponsors and Collaborators
Andrew Zolopa
Rwanda Biomedical Center
Gilead Sciences
Investigators
Principal Investigator: Andrew Zolopa, MD Stanford University
  More Information

No publications provided

Responsible Party: Andrew Zolopa, Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT02104700     History of Changes
Other Study ID Numbers: Near Rwanda, ISR-In-US-264-0123
Study First Received: April 1, 2014
Last Updated: April 1, 2014
Health Authority: Rwanda: Ministry of Health

Keywords provided by Stanford University:
HIV

Additional relevant MeSH terms:
Nevirapine
Tenofovir
Tenofovir disoproxil
Emtricitabine
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 29, 2014