Status:
TERMINATED
RESIST-2: 2nd-line ART for HIV-2 Infection
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Clinique des Maladies Infectieuses, CHNU de Fann, Dakar, Senegal
Centre de Sante de Ziguinchor, Casamance, Senegal
Conditions:
HIV-2 Infection
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2020
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT03394196
Start Date
July 4 2018
End Date
May 31 2020
Last Update
January 25 2021
Active Locations (2)
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1
Centre de Sante de Ziguinchor
Ziguinchor, Casamance, Senegal
2
Clinique des Maladies Infectieuses Ibrahima DIOP Mar/CRCF, Centre Hospitalier Universitaire de Fann
Dakar, Senegal