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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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1 February 2021 |
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Main ID: |
NCT03394196 |
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Date of registration:
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14/12/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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RESIST-2: 2nd-line ART for HIV-2 Infection
RESIST-2 |
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Scientific title:
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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 |
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Date of first enrolment:
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July 4, 2018 |
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Target sample size:
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152 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT03394196 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Senegal
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Contacts
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Name:
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Geoffrey S Gottlieb, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Washington |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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HIV-2 Infection
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Intervention(s)
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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)
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Diagnostic Test: HIV-2 Genotypic Drug Resistance Testing using DBS
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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)
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Drug: 2nd line ART (Tenofovir DF 300mg QD + Lamividine 300mg QD or Emtricitabine 200mg QD + Lopinavir/Ritonavir 400/100mg BID + Raltegravir 400mg BID )
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Primary Outcome(s)
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HIV-2 ARV resistance on 2nd line ART
[Time Frame: up to 3 years]
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Death
[Time Frame: up to 3 years]
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Loss to follow up
[Time Frame: 1 year]
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Virologic Failure on 2nd line ART
[Time Frame: up to 3 years]
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Secondary Outcome(s)
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New WHO stage 3 or 4 event > 6 months after starting ART
[Time Frame: up to 3 years]
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CD4 T-cell count trajectory
[Time Frame: up to 3 year after starting 2nd-line ART]
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Grade 3 or 4 adverse events
[Time Frame: up to 3 years]
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Secondary ID(s)
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STUDY00000228
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R01AI120765
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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