Terminé

A Phase II Study of Low-Dose Interleukin-2 by Subcutaneous Injection in Combination With Antiretroviral Therapy Versus Antiretroviral Therapy Alone in Patients With HIV-1 Infection and at Least 3 Months Stable Antiretroviral Therapy

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Ce qui est testé

Aldesleukin

Médicament
Qui peut participer

HIV Infections

À partir de 18 ans
Comment se déroule l'étude

Étude thérapeutique

Phase 2
Interventionnel

Résumé

Sponsor principalNational Institute of Allergy and Infectious Diseases (NIAID)
Dernière mise à jour : 28 octobre 2021
Issu d'une base de données validée par les autorités. Revendiquer cette étude

PRIMARY: To examine the effect of aldesleukin ( IL-2 ) on viral activity in the blood. To determine the safety of low-dose IL-2 in combination with antiretroviral therapy versus antiretroviral therapy alone. SECONDARY: To examine delayed type hypersensitivity responses to skin test antigens and antibody responses to protein and polysaccharide vaccines. The profound immune impairment that results from HIV-1 infection is due, at least in part, to the loss of CD4+ T cells and the cytokines these cells secrete, especially IL-2 and interferon-gamma. Antiretroviral agents do not directly address the problem of immune impairment. Replacement of IL-2 at nontoxic doses may prevent or delay clinical immunosuppression and its attendant opportunistic infections. Also, since patients with HIV-1 infection respond suboptimally to routine protein and polysaccharide immunizations, IL-2 may provide an adjuvant effect on vaccine responses. The profound immune impairment that results from HIV-1 infection is due, at least in part, to the loss of CD4+ T cells and the cytokines these cells secrete, especially IL-2 and interferon-gamma. Antiretroviral agents do not directly address the problem of immune impairment. Replacement of IL-2 at nontoxic doses may prevent or delay clinical immunosuppression and its attendant opportunistic infections. Also, since patients with HIV-1 infection respond suboptimally to routine protein and polysaccharide immunizations, IL-2 may provide an adjuvant effect on vaccine responses. Patients are randomized initially to receive their own antiretroviral therapy alone or in combination with IL-2 for 24 weeks, after which each group is crossed over to the other treatment assignment (i.e., IL-2 is either added or deleted from the regimen) for an additional 24 weeks. Patients who are vaccine eligible receive influenza, tetanus and diphtheria toxoid, and meningococcal polysaccharide vaccines at week 4, and those who have not received pneumococcal vaccine prior to study entry will receive it at week 8.

Titre officielA Phase II Study of Low-Dose Interleukin-2 by Subcutaneous Injection in Combination With Antiretroviral Therapy Versus Antiretroviral Therapy Alone in Patients With HIV-1 Infection and at Least 3 Months Stable Antiretroviral Therapy 
Sponsor principalNational Institute of Allergy and Infectious Diseases (NIAID)
Dernière mise à jour : 28 octobre 2021
Issu d'une base de données validée par les autorités. Revendiquer cette étude

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design
104 participants à inclureNombre total de participants que l'essai clinique vise à recruter.
Traitement
Cette étude teste un ou plusieurs traitements pour évaluer leur efficacité contre une maladie ou un problème de santé spécifique. L'objectif est de voir si un nouveau médicament ou une thérapie fonctionne mieux, ou provoque moins d'effets secondaires que les options existantes.

Comment les traitements sont administrés aux participants
Les participants sont répartis en groupes distincts, chaque groupe recevant un traitement différent en même temps. Cela permet de comparer directement l'efficacité de plusieurs traitements.

Autres façons d'administrer les traitements
Groupe unique
: tous les participants reçoivent le même traitement.

Affectation croisée
: les participants passent d'un traitement à un autre au cours de l'étude.

Plan factoriel
: les participants reçoivent des combinaisons de traitements pour évaluer leurs interactions.

Plan séquentiel
: les traitements sont administrés successivement selon un ordre prédéterminé, pouvant varier selon la réaction du participant.

Autre type d'attribution
: L'attribution des traitements ne suit pas de schéma standard ni de protocole prédéfini.

Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères
Tout sexeLe sexe biologique des participants éligibles à s'inscrire.
À partir de 18 ansTranche d'âge des participants éligibles à participer.
Volontaires sains non autorisésIndique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.
Conditions
Pathologie
HIV Infections
Critères

Inclusion Criteria Concurrent Medication: Allowed: * PCP prophylaxis. * Therapy for an opportunistic infection that develops on study, with the exception of foscarnet for CMV disease or resistant Herpes simplex. * Systemic corticosteroids ONLY IF given for no longer than 21 days for acute PCP. * Topical corticosteroids to areas separate from a skin test or IL-2 injection site. * Acyclovir up to 1000 mg/day as maintenance for recurrent genital Herpes. * Erythropoietin and filgrastim. * Antiemetics. * Antibiotics as clinically indicated. * Elective standard immunizations at week 8 or later. Concurrent Treatment: Allowed: * Local radiation therapy. Prior Medication: Required: * Stable, approved antiretroviral therapy for at least 2 months (was 3 months, amended 3/26/96) prior to study entry. Patients must have: * HIV seropositivity. * CD4 count 300 - 700 cells/mm3. * Stable antiretroviral therapy for at least 2 months (was 3 months, amended 3/26/96) prior to study entry. * No history of AIDS-defining illness except for limited cutaneous Kaposi's sarcoma. * Normal EKG (isolated nonspecific ST and T wave changes permitted). NOTE: * This protocol is approved for prisoner participation. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Malignancy requiring systemic or local cytotoxic chemotherapy. * Untreated thyroid disease. * Asthma requiring intermittent or chronic inhalation or systemic therapy. * Any medical condition that precludes study entry. Concurrent Medication: Excluded: * Antianginal agents such as nitrates, calcium channel blockers, beta blockers, and antiarrhythmics. * Systemic or local cytotoxic chemotherapy. * Interferons. * Interleukins other than study drug. * Pentoxifylline ( Trental ). * Acetylcysteine ( NAC ). * Sargramostim ( GM-CSF ). * Dinitrochlorobenzene ( DCNB ). * Thymosin alpha 1. * Thymopentin. * Inosiplex ( Isoprinosine ). * Polyribonucleoside ( Ampligen ). * Ditiocarb sodium ( Imuthiol ). * Therapeutic HIV vaccines. * Investigational antiretroviral agents such as lamivudine ( 3TC ) and tat and protease inhibitors. * Foscarnet. * Aspirin. * Immune globulin ( IVIG ). * Thalidomide. * Systemic corticosteroids (permitted for 21 days or less for PCP treatment only). Concurrent Treatment: Excluded: * Ongoing transfusion. Patients with the following prior conditions are excluded: * History of autoimmune disease, including inflammatory bowel disease and psoriasis (although autoimmune thyroid disease that is stable is allowed). * Clinically significant CNS disease or seizures that have been active within 1 year prior to study entry. Prior Medication: Excluded: * IL-2 within 3 months prior to study entry. * Any immunomodulatory therapy within 4 weeks prior to study entry. * Foscarnet within 4 weeks prior to study entry. * Acute therapy for an opportunistic infection within 14 days prior to study entry. Active alcohol or substance abuse that would compromise study compliance.



Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.
Cette étude comporte 10 sites
Suspendu
Alabama Therapeutics CRSBirmingham, United StatesVoir le site
Suspendu
University of Colorado Hospital CRSAurora, United States
Suspendu
Indiana Univ. School of Medicine, Infectious Disease Research ClinicIndianapolis, United States
Suspendu
SUNY - Buffalo, Erie County Medical Ctr.Buffalo, United States

Terminé10 Centres d'Étude