N/A
N=114
Analytical Treatment Interruption in HIV Positive Patients
HIV-1 Infection
Bottom Line
View on ClinicalTrials.gov: NCT02590354 ↗Enrolled (actual)
114
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Assessment of the Number of Participants With a HIV Plasma Viral Load Below the Lower Limit of Detection 48 Weeks Following Interruption of Antiretroviral Treatment — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ART interruption (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Institute of Tropical Medicine, Belgium
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assessment of the Number of Participants With a HIV Plasma Viral Load Below the Lower Limit of Detection 48 Weeks Following Interruption of Antiretroviral Treatment |
— | — |
| SECONDARY Number of Patients With and the Severity of Adverse Events That Are Related to the Study Intervention, Graded According to NCI CTCAE Version 4.0 |
1; 0; 0; 0; 15; 1 | — |
| SECONDARY Evaluation of the Reservoir Replenishment Upon Interruption of Antiretroviral Treatment (TI) by Quantifying the Viral Reservoir at Baseline (i.e. Just Before TI) and at Viral Rebound (Total HIV DNA). |
37.5; 22.5; 27.5; 46.5; 38.0; 83.5 | — |
| SECONDARY Evaluation of the Reservoir Replenishment Upon Interruption of Antiretroviral Treatment (TI) by Quantifying the Viral Reservoir at Baseline (i.e. Just Before TI) and at Viral Rebound (Unspliced RNA). |
2; 7.0; 7.5; 23.5; 30.5; 34.5 | — |
| SECONDARY Assessment of the Kinetics of HIV Viral Load Rebound After Treatment Interruption Based on the Repetitive Plasma Viral Load Measurements. |
19; 19; 19; 1223; 4020; 3480 | — |
Summary
HIV-1 infected patients with normal peripheral blood CD4+ T-cell counts and undetectable viral load will be recruited in four Belgian HIV reference centers. Selected patients will undergo a two-step screening in which a viral reservoir measurement will be performed and among those with a very low viral reservoir an analytical treatment interruption of their longstanding antiretroviral therapy (ART). There is no randomization foreseen. Patients will receive an intense clinical and laboratory follow-up during 48 weeks followed by 12 weeks post intervention.
Eligibility Criteria
Inclusion Criteria
- Able and willing to provide written informed consent
- Men and women age ≥ 18 and = 500/μl for a period of at least 3 months prior study entry
- Nadir CD4+ T-cell count is ≥300/μl. A lower nadir CD4+ T-cell count will be allowed if measured at time of acute infection as far as the relative CD4+ count remains above 20%. An acute infection is defined as an association of a clinical picture of retroviral syndrome together with a seroconversion in HIV serology or an incomplete confirmation test.
- Plasma viral load 5 x upper limit on normal range (ULN). One retest within 14 days is allowed.
- Receipt of any immune modulator or suppressor within 30 days prior study entry, including, but not limited to drugs such as corticosteroids (with the exception of corticosteroids used for topical use), granulocyte-macrophage colony-stimulating factor, interleukin (IL)-2, IL-7 and IL-15.
- Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- Participation in other interventional studies involving investigational drug.
Data sourced from ClinicalTrials.gov (NCT02590354). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.