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RESIST-2: 2nd-line ART for HIV-2 Infection (RESIST-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03394196
Recruitment Status : Active, not recruiting
First Posted : January 9, 2018
Last Update Posted : January 22, 2020
Sponsor:
Collaborators:
Clinique des Maladies Infectieuses, CHNU de Fann, Dakar, Senegal
Centre de Sante de Ziguinchor, Casamance, Senegal
Janssen Pharmaceutica
Merck Sharp & Dohme Corp.
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Geoffrey S. Gottlieb, University of Washington

Tracking Information
First Submitted Date  ICMJE December 14, 2017
First Posted Date  ICMJE January 9, 2018
Last Update Posted Date January 22, 2020
Actual Study Start Date  ICMJE July 4, 2018
Estimated Primary Completion Date May 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2018)
  • Death [ Time Frame: up to 3 years ]
    all cause mortality
  • Loss to follow up [ Time Frame: 1 year ]
    no contact with study for 1 year
  • Virologic Failure on 2nd line ART [ Time Frame: up to 3 years ]
    VL >250 copies/ml
  • HIV-2 ARV resistance on 2nd line ART [ Time Frame: up to 3 years ]
    by DBS genotyping
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2018)
  • New WHO stage 3 or 4 event > 6 months after starting ART [ Time Frame: up to 3 years ]
    BY WHO criteria
  • Grade 3 or 4 adverse events [ Time Frame: up to 3 years ]
    DAIDS definitions
  • CD4 T-cell count trajectory [ Time Frame: up to 3 year after starting 2nd-line ART ]
    delta CD4 count per year
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE RESIST-2: 2nd-line ART for HIV-2 Infection
Official Title  ICMJE Implementation and Evaluation of an HIV-2 Viral Load and ARV Resistance Informed Algorithm for 2nd-line ART in HIV-2 Infected Patients in the Initiative Sénégalaise d'Accès Aux Antirétroviraux (ISAARV) Program
Brief Summary Prospective, longitudinal, open label, HIV-2 viral load and antiretroviral resistance informed 2nd-line ARV implementation study.
Detailed Description

Prospective, longitudinal, open label, HIV-2 viral load and antiretroviral resistance informed 2nd-line ARV implementation study.

DURATION

Up to 3 years

SAMPLE SIZE

150

POPULATION

HIV-2-infected adults (≥18 years old); ARV-experienced, with virologic failure on 1st-line 2NRTI+LPV/r in the ISAARV program.

STRATIFICATION

By ARV resistance

REGIMEN OR INTERVENTION

Intervention: Implement real time ARV resistance testing using rapid DBS/CS ARV Regimens: Based on ARV resistance testing

  1. No resistance: Current ART: Zidovudine 300mg BID + Lamivudine 150mg BID or Tenofovir DF 300mg QD + Lamividine 300mg QD or Emtricitabine 200mg QD + Lopinavir/Ritonavir 400/100mg BID (AZT/3TC or TDF/3TC or TDF/FTC + LPV/r) +Enhanced Adherence Counseling
  2. NRTI resistance only: Tenofovir DF 300mg QD + Lamividine 300mg QD or Emtricitabine 200mg QD + Lopinavir/Ritonavir 400/100mg BID + Raltegravir 400mg BID (TDF/FTC or TDF/3TC + LPV/r + RAL) + Enhanced Adherence Counseling
  3. NRTI-PI resistance: Tenofovir DF 300mg QD + Lamividine 300mg QD or Tenofovir DF 300mg QD + Emtricitabine 200mg QD + Darunavir 600mg BID-Ritonavir 100mg BID + Raltegravir 400mg BID (TDF/FTC or TDF/3TC +DRV/r2 + RAL) + Enhanced Adherence Counseling
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV-2 Infection
Intervention  ICMJE
  • Diagnostic Test: HIV-2 Genotypic Drug Resistance Testing using DBS
    Real time HIV-2 genotypic drug resistance testing using dried blood spots and consensus sequencing.
  • Drug: 2nd line ART ( Zidovudine 300mg BID + Lamivudine 150mg BID or Tenofovir DF 300mg QD + Lamividine 300mg QD or Emtricitabine 200mg QD + Lopinavir/Ritonavir 400/100mg BID)
    1. No resistance: Continue Current ART: Zidovudine 300mg BID + Lamivudine 150mg BID or Tenofovir DF 300mg QD + Lamividine 300mg QD or Emtricitabine 200mg QD + Lopinavir/Ritonavir 400/100mg BID (AZT/3TC or TDF/3TC or TDF/FTC + LPV/r) + Enhanced Adherence Counseling
  • Drug: 2nd line ART (Tenofovir DF 300mg QD + Lamividine 300mg QD or Emtricitabine 200mg QD + Lopinavir/Ritonavir 400/100mg BID + Raltegravir 400mg BID )
    2. NRTI resistance only: Tenofovir DF 300mg QD + Lamividine 300mg QD or Emtricitabine 200mg QD + Lopinavir/Ritonavir 400/100mg BID + Raltegravir 400mg BID (TDF/FTC or TDF/3TC + LPV/r + RAL) + Enhanced Adherence Counseling
  • Drug: 2nd line ART (Tenofovir DF 300mg QD + Lamividine 300mg QD or Tenofovir DF 300mg QD + Emtricitabine 200mg QD + Darunavir 600mg BID-Ritonavir 100mg BID +Raltegravir 400mg BID)
    3. NRTI-PI resistance: Tenofovir DF 300mg QD + Lamividine 300mg QD or Tenofovir DF 300mg QD + Emtricitabine 200mg QD + Darunavir 600mg BID-Ritonavir 100mg BID +Raltegravir 400mg BID (TDF/FTC or TDF/3TC +DRV/r2 + RAL) + Enhanced Adherence Counseling
Study Arms  ICMJE
  • Experimental: No HIV-2 resistance
    Interventions:
    • Diagnostic Test: HIV-2 Genotypic Drug Resistance Testing using DBS
    • Drug: 2nd line ART ( Zidovudine 300mg BID + Lamivudine 150mg BID or Tenofovir DF 300mg QD + Lamividine 300mg QD or Emtricitabine 200mg QD + Lopinavir/Ritonavir 400/100mg BID)
  • Experimental: HIV-2 NRTI resistance only
    Interventions:
    • Diagnostic Test: HIV-2 Genotypic Drug Resistance Testing using DBS
    • Drug: 2nd line ART (Tenofovir DF 300mg QD + Lamividine 300mg QD or Emtricitabine 200mg QD + Lopinavir/Ritonavir 400/100mg BID + Raltegravir 400mg BID )
  • Experimental: HIV-2 NRTI and PI resistance
    Interventions:
    • Diagnostic Test: HIV-2 Genotypic Drug Resistance Testing using DBS
    • Drug: 2nd line ART (Tenofovir DF 300mg QD + Lamividine 300mg QD or Tenofovir DF 300mg QD + Emtricitabine 200mg QD + Darunavir 600mg BID-Ritonavir 100mg BID +Raltegravir 400mg BID)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 5, 2018)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date May 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. HIV-2 infection: confirmed by Determine (Alere, Inc.) & Immunocomb II (Alere, Inc.) or equivalent
  2. Failing 1st line antiretroviral therapy (e.g. AZT/3TC or TDF/XTC + LPV/r; previous 3 NRTI or 2 NRTI regimens; previous Indinavir (IDV) use, current or previous Atazanavir (ATV) use; previous NNRTI use)
  3. For females of reproductive potential: negative serum or urine pregnancy test
  4. Men and women age >/=18 years
  5. Ability and willingness of subject to provide informed consent

Exclusion Criteria:

  1. HIV-1 or HIV-1/HIV-2 dual infection
  2. Pregnancy or Breast-feeding
  3. Lab Abnormalities

    • AST/ALT >2.5 X ULN
    • CrCl <30
  4. Current or previous use of Integrase Inhibitors or Darunavir
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Senegal
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03394196
Other Study ID Numbers  ICMJE STUDY00000228
R01AI120765 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: IPD shared on request with ORB approval on final cleaned dataset
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: at end of study
Access Criteria: IRB approval
Responsible Party Geoffrey S. Gottlieb, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE
  • Clinique des Maladies Infectieuses, CHNU de Fann, Dakar, Senegal
  • Centre de Sante de Ziguinchor, Casamance, Senegal
  • Janssen Pharmaceutica
  • Merck Sharp & Dohme Corp.
  • National Institute of Allergy and Infectious Diseases (NIAID)
Investigators  ICMJE
Principal Investigator: Geoffrey S Gottlieb, MD PhD University of Washington
PRS Account University of Washington
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP