RESIST-2: 2nd-line ART for HIV-2 Infection
- Conditions
- HIV-2 Infection
- Interventions
- Diagnostic Test: HIV-2 Genotypic Drug Resistance Testing using DBS
- Registration Number
- NCT03394196
- Lead Sponsor
- University of Washington
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 152
- HIV-2 infection: confirmed by Determine (Alere, Inc.) & Immunocomb II (Alere, Inc.) or equivalent
- 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)
- For females of reproductive potential: negative serum or urine pregnancy test
- Men and women age >/=18 years
- Ability and willingness of subject to provide informed consent
-
HIV-1 or HIV-1/HIV-2 dual infection
-
Pregnancy or Breast-feeding
-
Lab Abnormalities
- AST/ALT >2.5 X ULN
- CrCl <30
-
Current or previous use of Integrase Inhibitors or Darunavir
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description No HIV-2 resistance HIV-2 Genotypic Drug Resistance Testing using DBS - HIV-2 NRTI resistance only HIV-2 Genotypic Drug Resistance Testing using DBS - HIV-2 NRTI and PI resistance HIV-2 Genotypic Drug Resistance Testing using DBS - No HIV-2 resistance 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) - HIV-2 NRTI resistance only 2nd line ART (Tenofovir DF 300mg QD + Lamividine 300mg QD or Emtricitabine 200mg QD + Lopinavir/Ritonavir 400/100mg BID + Raltegravir 400mg BID ) - HIV-2 NRTI and PI resistance 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) -
- Primary Outcome Measures
Name Time Method Death up to 3 years all cause mortality
Loss to follow up 1 year no contact with study for 1 year
Virologic Failure on 2nd line ART up to 3 years VL \>250 copies/ml
HIV-2 ARV resistance on 2nd line ART up to 3 years by DBS genotyping
- Secondary Outcome Measures
Name Time Method New WHO stage 3 or 4 event > 6 months after starting ART up to 3 years BY WHO criteria
Grade 3 or 4 adverse events up to 3 years DAIDS definitions
CD4 T-cell count trajectory up to 3 year after starting 2nd-line ART delta CD4 count per year
Trial Locations
- Locations (2)
Clinique des Maladies Infectieuses Ibrahima DIOP Mar/CRCF, Centre Hospitalier Universitaire de Fann
🇸🇳Dakar, Senegal
Centre de Sante de Ziguinchor
🇸🇳Ziguinchor, Casamance, Senegal