Adults 18 to 64, any sex, with HIV-1 Infection. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Assessment of the Number of Participants With a HIV Plasma Viral Load Below the Lower Limit of Detection 48 Weeks Following Interruption of Antiretroviral TreatmentPrimary· 48 weeks after treatment interruption
The number of post treatment controllers (PTC - i.e. patients under ART at baseline that show low peripheral blood proviral DNA and still will show sustained viral suppression at 48 weeks after treatment interruption) will be determined. The assessment will be based on the plasma viral load (expressed in copies/ml) measured two-weekly (or four-weekly after W12) until W48 after treatment interruption. Patients below the lower limit of detection (\<50 HIV RNA copies/ml plasma) at 48 weeks after treatment interruption will be considered as PTC.
Group
Value
95% CI
Treatment Interruption
0
Number of Patients With and the Severity of Adverse Events That Are Related to the Study Intervention, Graded According to NCI CTCAE Version 4.0Secondary· 23 months
Confirmation of the safety of a treatment interruption strategy in selected patients will be based on the number and intensity of AEs graded according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE) on a five-point scale (Grade 1 to 5: Mild, Moderate, Severe, Life-threatening and Death).
Fatigue
Group
Value
95% CI
Treatment Interruption
1
Treatment Interruption
0
Treatment Interruption
0
Treatment Interruption
0
Influenza-like illness
Group
Value
95% CI
Treatment Interruption
1
Treatment Interruption
0
Treatment Interruption
0
Treatment Interruption
0
Oropharyngeal pain
Group
Value
95% CI
Treatment Interruption
1
Treatment Interruption
0
Treatment Interruption
0
Treatment Interruption
0
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).Secondary· At screening, baseline, week 2, week 4, week 6, week 8 and at 12 weeks after relapse
Assessment of the viral reservoir magnitude on cryopreserved Peripheral Blood Mononuclear Cells (PBMCs) prior and after treatment interruption by means of Total HIV DNA.
Screening
Group
Value
95% CI
Phase 2 - Treatment Interruption
37.5
11.5 – 55.5
Baseline
Group
Value
95% CI
Phase 2 - Treatment Interruption
22.5
4.0 – 53.5
Week 2
Group
Value
95% CI
Phase 2 - Treatment Interruption
27.5
11.0 – 69
Week 4
Group
Value
95% CI
Phase 2 - Treatment Interruption
46.5
18 – 127
Week 6
Group
Value
95% CI
Phase 2 - Treatment Interruption
38.0
22 – 141.5
Week 8
Group
Value
95% CI
Phase 2 - Treatment Interruption
83.5
82 – 85
Post week 12
Group
Value
95% CI
Phase 2 - Treatment Interruption
42.5
29 – 117
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).Secondary· At screening, baseline, week 2, week 4, week 6, week 8 and at 12 weeks after relapse
Assessment of the viral reservoir magnitude on cryopreserved Peripheral Blood Mononuclear Cells (PBMCs) prior and after treatment interruption by means of unspliced RNA.
Screening
Group
Value
95% CI
Phase 2 - Treatment Interruption
2
0.0 – 3.5
Baseline
Group
Value
95% CI
Phase 2 - Treatment Interruption
7.0
4.0 – 16.5
Week 2
Group
Value
95% CI
Phase 2 - Treatment Interruption
7.5
5.0 – 19.5
Week 4
Group
Value
95% CI
Phase 2 - Treatment Interruption
23.5
5.0 – 179
Week 6
Group
Value
95% CI
Phase 2 - Treatment Interruption
30.5
10.5 – 177
Week 8
Group
Value
95% CI
Phase 2 - Treatment Interruption
34.5
31 – 38
Post week 12
Group
Value
95% CI
Phase 2 - Treatment Interruption
12
5 – 15
Assessment of the Kinetics of HIV Viral Load Rebound After Treatment Interruption Based on the Repetitive Plasma Viral Load Measurements.Secondary· At screening, baseline, week 2, week 4, week 6, week 8, End of Intervention (relapse), 4 weeks after relapse and 12 weeks after relapse
The kinetics will be on the plasma viral load (expressed in copies/ml) measured two-weekly (or four-weekly after W12) until W48 after treatment interruption. A viral load of 19 means \<20 copies/mL (lower limit of detection).
Screening
Group
Value
95% CI
Phase 2 - Treatment Interruption
19
19 – 19
Baseline
Group
Value
95% CI
Phase 2 - Treatment Interruption
19
19 – 19
Week 2
Group
Value
95% CI
Phase 2 - Treatment Interruption
19
19 – 55.5
Week 4
Group
Value
95% CI
Phase 2 - Treatment Interruption
1223
26 – 40600
Week 6
Group
Value
95% CI
Phase 2 - Treatment Interruption
4020
2110 – 21100
Week 8
Group
Value
95% CI
Phase 2 - Treatment Interruption
3480
3480 – 3480
En of Intervention (moment of relapse)
Group
Value
95% CI
Phase 2 - Treatment Interruption
28000
2330 – 44900
Post week 4
Group
Value
95% CI
Phase 2 - Treatment Interruption
22
19 – 165
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected over the whole study period (from start of treatment interruption until end of follow-up period which was 12 weeks after relapse and treatment restart)..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
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· recruiting
NCT06602622 — Change in Body Weight and BMI in PWH with DOR/3TC/TDF Compared with INSTI
· Phase 4
· recruiting
NCT05705349 — DOR/ISL in HIV-1 Antiretroviral Treatment-naïve Participants (MK-8591A-053)
· Phase 3
· active not recruiting
NCT05631093 — A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Vir
· Phase 3
· active not recruiting
NCT05630755 — A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Vir
· Phase 3
· active not recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Institute of Tropical Medicine, Belgium
Last refreshed: 24 September 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02590354.