Dolutegravir Plus 2 NRTIs, in Treatment-Naïve HIV-2 Infected Subjects
|ClinicalTrials.gov Identifier: NCT03224338|
Recruitment Status : Completed
First Posted : July 21, 2017
Last Update Posted : September 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|HIV II Infection||Drug: Dolutegravir 50 mg||Phase 2|
Subjects who fulfill all inclusion criteria and none of the exclusion criteria, after giving informed consent, will be eligible for participation in this study. At the Visit 2 (Day1) subjects will receive the study medication and instructions for its administration. Thereafter, subjects will return to the investigational site at week 4, 12, 24, 36 and 48, for efficacy and safety assessments.
Subjects who meet the virologic failure criteria will return to the investigational site approximately one week later to repeat viral RNA testing (Virologic Failure Confirmation visit). If virologic failure is confirmed and the viral load meets the criteria for resistance testing, viral resistance testing will then be performed.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Multicenter, Single-Arm, Open-Label Clinical Trial to Evaluate the Safety and Efficacy of Triple Therapy With Dolutegravir Plus 2 NRTIs, in Treatment-Naïve HIV-2 Infected Subjects|
|Actual Study Start Date :||April 5, 2017|
|Actual Primary Completion Date :||July 2, 2019|
|Actual Study Completion Date :||July 2, 2019|
|Experimental: : Dolutegravir (DTG)||
Drug: Dolutegravir 50 mg
Dolutegravir will be used in combination with 2 nucleoside reverse transcriptase inhibitors (NRTIs). The NRTIs used in combination with DTG will be abacavir (ABC) plus lamivudine (3TC) or tenofovir (TDF) plus emtricitabine (FTC), which is in line with the current standard of care. The combination ABC/3TC/DTG will be preferential except in case of hepatitis B co-infection or in case the subject has a positive HLA-B*5701 allele screening assessment.
- Efficacy analysis- treatment efficacy, as measured by the "overall treatment success defined as proportion of patients with "global success" at week 48. [ Time Frame: 48 Weeks ]The primary objective of this study is to evaluate the efficacy of DTG in combination with two NRTIs [ABC/3TC or TDF/FTC] in the treatment of HIV-2 treatment-naïve subjects, as measured by the proportion of subjects achieving a plasma viral load of <40 copies/mL and/or by the change from baseline in CD4 cell count and in CD4/CD8 ratio at Week 48. Global success" is a composite variable defined as a plasma HIV-2 RNA viral load <40 copies/mL and a delta of CD4 depending on the initial CD4 count (CD4 delta >+100 cells/mm3 for initial CD4s ≤ 500 cells/mm3; or CD4delta > +50 cells/mm3 for initial CD4s > 500 cells/mm3).
- Study treatment immunological effect [ Time Frame: 12, 24 and 48 Weeks ]
To evaluate the study treatment immunological effect, as measured by the change from baseline in CD4 cell count and the CD4/CD8 ratio at Week 48.
as measured by the change from baseline in CD4 cell count and the CD4/CD8 ratio at Week 48. Change from Baseline in CD4 Cell Count and CD4/CD8 ratio Change from baseline in CD4 cell count and the CD4/CD8 ratio will be estimated at each time point with CD4 and CD8 cell count collection with a key interest at Week 12, 24 and 48.
- Study treatment immunological effect [ Time Frame: 12, 24 and 48 Weeks ]Proportions of subjects achieving HIV-2 RNA < 40 copies/mL. The proportions of subjects achieving HIV-2 RNA <40 copies/mL will be estimated at Week 12, 24 and 48.
- Safety and tolerability of the study treatment, as assessed by review of the accumulated safety data. [ Time Frame: 24 weeks or rebounder at least one week apart afte rinitial response ]
The following clinical and laboratory adverse experiences will be summarized:
Subjects with at least one adverse experience. Subjects with at least one drug related adverse experience. Subjects with at least one serious adverse experience. Subjects with at least one serious and drug related adverse experience, Subjects who discontinued study therapy due to an adverse experience.
- Antiretroviral activity [ Time Frame: 48 Weeks ]The exploratory objective of this study is to evaluate the antiretroviral activity of DTG in combination with two NRTIs [ABC/3TC or TDF/FTC] against HIV-2, as measured by the Time to Virologic Response (TVR)
- Antiretroviral activity [ Time Frame: 48 Weeks ]The exploratory objective of this study is to evaluate the antiretroviral activity of DTG in combination with two NRTIs [ABC/3TC or TDF/FTC] against HIV-2, as measured by the Time to Loss Of Virologic Response (TLOVR).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03224338
|Centro Hospitalar de Lisboa Central Hospital Curry Cabral|
|Centro Hospitalar de Lisboa Ocidental Hospital de Egas Moniz|
|Centro Hospitalar Lisboa Norte Hospital de Santa Maria|
|Hospital Beatriz Ângelo Loures|
|Hospital Garcia de Orta|
|Hospital Professor Doutor Fernando Fonseca Amadora|