Effects of Dolutegravir Based Regimen on HIV-1 Reservoir and Immune Activation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

202 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-09-30

Brief Summary

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We aim at comparing markers of HIV reservoir, monocyte function and immune activation between antiretroviral therapy (ART)-naïve (chronic infection or primary infection), ART-controlled or ART-failing HIV infected adults initiating a dolutegravir (DTG)-based regimen. The investigators' purpose is to measure cell associated HIV-1 DNA, monocyte function \[soluble CD14 (sCD14), soluble CD163 (sCD163)\], and immune activation \[neopterine, interleukin-6 (IL-6) and high-sensitivity C-reactive protein (hsCRP)\] biomarkers at different time points between baseline and week 48 post DTG-based regimen initiation in each group.

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Detailed Description

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Conditions

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HIV-1 Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ART-naive (primary infection)

ART-naive (primary infection) HIV infected adults

Blood tube bottom analyses

Intervention Type OTHER

ART-naïve (chronic infection)

ART-naïve (chronic infection) HIV infected adults

Blood tube bottom analyses

Intervention Type OTHER

ART-controlled

ART-controlled HIV infected adults

Blood tube bottom analyses

Intervention Type OTHER

ART-failing

ART-failing HIV infected adults

Blood tube bottom analyses

Intervention Type OTHER

Interventions

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Blood tube bottom analyses

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male or female aged from de 18 to 80 years
* Patient starting a DTG-regimen
* Patients agreeing to use methods of birthcontrol while on the study and during the 6 weeks after stopping DTG treatment
* Signed and dated written informed consent is obtained from the subject or the subject's legal representative prior to screening

Exclusion Criteria

* Women who are pregnant or breastfeeding
* HBV or HCV coinfection
* Participation in another clinical drug or device trial where the last dose of drug was within the past 30 days or an investigational medical device is currently implanted
* Documented resistance to DTG
* Allergy or intolerance to the study drugs or their components or drugs of their class
* Any acute or verified Grade 4 laboratory abnormality (with the exception of Grade 4 lipids) at Screening.
* Coadministration with Dofelitide

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No