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Vedolizumab (Anti-alpha4beta7) in Subjects With HIV Infection Undergoing Analytical Treatment Interruption
Phase 1 trial testing Entyvio (Vedolizumab) in HIV in 26 participants. Completed in 4 March 2019.
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 26 |
| Start date | 28 May 2016 |
| Primary completion | 4 March 2019 |
| Estimated completion | 4 March 2019 |
| Sites | 1 location across United States |
National Institute of Allergy and Infectious Diseases (NIAID)
Adults 18 to 65, any sex, with HIV. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The primary endpoint was the number of grade 2 or higher adverse events, including serious adverse events, that were probably or definitely related to vedolizumab.
| Group | Value | 95% CI |
|---|---|---|
| Vedolizumab in HIV-infected Adults on cART | 11 |
The secondary endpoint was defined as number of subjects who experienced plasma viremia following ATI and met criteria to restart cART before week 48 \[a confirmed \>30% decline in baseline CD4+ T Cell count or an absolute CD4+ T Cell count in the setting of detectable HIV viremia (\>40 copies/mL); a sustained (\>4weeks) HIV RNA level of \> 1000 copies/mL, or any HIV related symptoms or pregnancy.\]
| Group | Value | 95% CI |
|---|---|---|
| Vedolizumab in HIV-infected Adults on cART | 13 |
Time frame: up to 72 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Vedolizumab in HIV-infecte… |
|---|---|---|
| Neck pain | Musculoskeletal and connective tissue disorders | — |
| Reaction | System | Vedolizumab in HIV-infecte… |
|---|---|---|
| Blood glucose increased | Investigations | — |
| Nasopharyngitis | Infections and infestations | — |
| Blood bicarbonate decreased | Investigations | — |
| Blood phosphorus decreased | Investigations | — |
| Upper respiratory tract infection | Infections and infestations | — |
| Blood creatinine increased | Investigations | — |
| Fatigue | General disorders | — |
| Alanine aminotransferase increased | Investigations | — |
| Bronchitis | Infections and infestations | — |
| Gastroenteritis | Infections and infestations | — |
| Aspartate aminotransferase increased | Investigations | — |
| Blood potassium decreased | Investigations | — |
| Headache | Nervous system disorders | — |
| Diarrhoea | Gastrointestinal disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Viral infection | Infections and infestations | — |
| Blood creatine phosphokinase increased | Investigations | — |
| Blood sodium decreased | Investigations | — |
| Blood sodium increased | Investigations | — |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | — |
| Dysuria | Renal and urinary disorders | — |
| Iron deficiency anaemia | Blood and lymphatic system disorders | — |
| Palpitations | Cardiac disorders | — |
| Tachycardia | Cardiac disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Hiatus hernia | Gastrointestinal disorders | — |
| Influenza like illness | General disorders | — |
| Pain | General disorders | — |
| Pyrexia | General disorders | — |
| Hypersensitivity | Immune system disorders | — |
| Acute sinusitis | Infections and infestations | — |
| Campylobacter gastroenteritis | Infections and infestations | — |
| Campylobacter infection | Infections and infestations | — |
| Epididymitis | Infections and infestations | — |
| Furuncle | Infections and infestations | — |
| Giardiasis | Infections and infestations | — |
| Gonorrhoea | Infections and infestations | — |
| Herpes simplex | Infections and infestations | — |
| Influenza | Infections and infestations | — |
Most-reported serious reactions: Neck pain.
Data from ClinicalTrials.gov NCT02788175 adverse events section.
Background: In most people infected with human immunodeficiency virus (HIV), their immune system cannot control HIV infection. They need drugs called combination antiretroviral therapy (cART) to control the HIV. When people stop cART treatment, their immune system cannot control the infection again. They can also become resistant to cART and have lasting side effects. Researchers want to test if the drug vedolizumab is effective at controlling HIV infection without the need for cART. Objective: To test if vedolizumab is safe and can control the amount of HIV in the blood when cART is not taken. Eligibility: People ages 18-65 who have HIV and are being treated with cART Design: Participants will be screened with: Physical exam Medical history Electrocardiogram: Soft, sticky patches on the chest, arms, and legs measure heart activity. Blood and urine tests Participants will have a baseline visit. This will be 2-5 hours each day for 1-2 days. It will include repeats of the screening tests and: Leukapheresis: Blood is removed through a needle in the arm. A machine separates the white blood cells from the blood. The rest of the blood is returned to the participant. Neurologic exam: The nerves and reflexes are tested. First vedolizumab infusion through an arm vein Participants will have visits every 4 weeks for 30 weeks. These will include: Vedolizumab infusions Repeats of baseline tests Participants will have more visits for blood draws. Participants will keep taking cART until after the week 22 infusion. After discontinuing cART at study week 22, participants will be seen every two weeks to monitor the CD4 count and the level of HIV in the blood. Some of these visits will occur in between infusion visits and will only take about 1 hour to complete. cART will be restarted if a participant's HIV levels go up to high, or if their CD4 cell counts decreases by too much. For the follow-up phase, participants will have visits every 4 weeks for 24 weeks. These will include blood tests and a physical exam. ...
8 peer-reviewed publications reference this trial (live from Europe PMC):
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