Overview

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

Status:
Terminated

Trial end date:
2020-05-31

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of Washington

Collaborators:

Centre de Sante de Ziguinchor, Casamance, Senegal
Clinique des Maladies Infectieuses, CHNU de Fann, Dakar, Senegal
Janssen Pharmaceutica
Merck Sharp & Dohme Corp.
National Institute of Allergy and Infectious Diseases (NIAID)

Treatments:

Darunavir
Emtricitabine
Lamivudine
Lopinavir
Raltegravir Potassium
Ritonavir
Tenofovir
Zidovudine

Criteria

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