Terminé

A Multicenter Study To Determine Foscarnet Dose Response in HIV Infected Patients With PGL and/or Constitutional Disease

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Ce qui est testé

Foscarnet sodium

Médicament
Qui peut participer

HIV Infections

À partir de 13 ans
Comment se déroule l'étude

Étude thérapeutique

Phase 1
Interventionnel

Résumé

Sponsor principalNational Institute of Allergy and Infectious Diseases (NIAID)
Dernière mise à jour : 3 novembre 2021
Issu d'une base de données validée par les autorités. Revendiquer cette étude

To determine the toxicity of low dose foscarnet administered for 4 weeks to HIV infected patients who are asymptomatic, have AIDS, or other HIV associated conditions and a CD4+ lymphocyte count < 500 cells/mm3. To obtain preliminary efficacy data. Although zidovudine (AZT) has been effective in treating some AIDS patients, AZT has toxic effects in many patients and other means of treating HIV-infected persons need to be evaluated. In vitro (test tube) studies have shown that the human herpes viruses are inhibited by foscarnet and that a number of retroviruses, including HIV, are sensitive to it. It is hoped that treatment of HIV-infected individuals with foscarnet during an early phase of HIV infections will reduce the risk of developing AIDS. Although zidovudine (AZT) has been effective in treating some AIDS patients, AZT has toxic effects in many patients and other means of treating HIV-infected persons need to be evaluated. In vitro (test tube) studies have shown that the human herpes viruses are inhibited by foscarnet and that a number of retroviruses, including HIV, are sensitive to it. It is hoped that treatment of HIV-infected individuals with foscarnet during an early phase of HIV infections will reduce the risk of developing AIDS. Patients are divided into three groups: (1) asymptomatic patients with or without persistent generalized lymphadenopathy (PGL) syndrome; (2) patients with AIDS; and (3) patients who have or have had mild to moderate signs or symptoms consistent with HIV infection. Patients are then randomly chosen to receive one of three different foscarnet doses. The drug is given for 4 weeks, by 1-hour infusion administered every 8 hours. In addition, those patients who are clinically stable and have not experienced severe toxicity at the end of the 4 weeks may continue treatment, in the form of a single daily dose of foscarnet to be administered 5 days per week. Blood samples are taken during treatment and at the first, fourth, and eighth week after treatment. If the patient is on maintenance, blood samples are taken weekly. Effective 7-17-89, patients entering the study are assigned to the lowest foscarnet dose. Patients receive daily treatment for 28 days. Patients who are clinically stable without severe toxicity at 4 weeks have the option of maintenance therapy with foscarnet.

Titre officielA Multicenter Study To Determine Foscarnet Dose Response in HIV Infected Patients With PGL and/or Constitutional Disease 
Sponsor principalNational Institute of Allergy and Infectious Diseases (NIAID)
Dernière mise à jour : 3 novembre 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
10 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 participants sont répartis entre les groupes de l'étude
Dans cette étude clinique, les participants sont répartis de manière aléatoire, comme lors d'un tirage au sort. Cela garantit l'équité et réduit les biais, rendant les résultats plus fiables. En attribuant les participants au hasard, les chercheurs peuvent comparer les traitements sans influence extérieure.

Autres méthodes de répartition
Répartition non aléatoire
: basée sur des critères spécifiques comme l'état de santé ou la décision du médecin.

Aucune (un seul groupe de participants)
: tous les participants reçoivent le même traitement, aucune répartition n'est nécessaire.

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 13 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: * Aerosolized pentamidine for secondary Pneumocystis carinii pneumonia (PCP) prophylaxis. * Short course therapy with oral acyclovir (ACV) = or \< 7 days. Short course therapy with ketoconazole = or \< 7 days for patients who are not responding to any other therapy. * Flurazepam. * Diphenhydramine. Prior Medication: Allowed: * Systemic therapy, prophylaxis or maintenance for an AIDS-defining opportunistic infection. Patients with any of the following findings may be included: * Asymptomatic HIV patients with or without lymphadenopathy. * Patients with AIDS as defined by the CDC surveillance case definitions. * Patients with past or present mild to moderate signs or symptoms consistent with HIV infection. * p24 antigen in the serum = or \> 60 pg/ml. Exclusion Criteria Co-existing Condition: Patients with the following will be excluded: * Ongoing systemic therapy / prophylaxis / maintenance for an AIDS-defining opportunistic infection. * Symptomatic visceral Kaposi's sarcoma (KS), progression of KS within the month prior to entry into the study, or with concurrent neoplasms other than KS or basal cell carcinoma of the skin or in situ carcinoma of the cervix. * Cytomegalovirus (CMV) retinitis. * AIDS dementia. Concurrent Medication: Excluded: * Antiretrovirals. * Immunomodulatory agents. * Corticosteroids Other systemic antiviral or antimicrobial agents. * Experimental medications. * Excluded on chronic basis and discouraged for \> 72 hours: * Acetaminophen. * Narcotics. * Aspirin. Concurrent Treatment: Excluded: * Transfusion dependency or requirement of 2 units of blood more than once per month. Patients with the following will be excluded: * Ongoing systemic therapy / prophylaxis / maintenance for an AIDS-defining opportunistic infection. * Symptomatic visceral Kaposi's sarcoma (KS), progression of KS within the month prior to entry into the study, or with concurrent neoplasms other than KS or basal cell carcinoma of the skin or in situ carcinoma of the cervix. * Cytomegalovirus (CMV) retinitis. * AIDS dementia. Prior Medication: Excluded within 30 days of study entry: * Antiretroviral agents (except ribavirin). * Immunomodulatory agents. * Excluded within 60 days of study entry: * Ribavirin. The last blood transfusion cannot have been given within 2 weeks of entry. Active substance abuse which could impair compliance with the protocol.



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 11 sites
Suspendu
Los Angeles County - USC Med CtrLos Angeles, United StatesVoir le site
Suspendu
USC School of Medicine / Norris Cancer HospLos Angeles, United States
Suspendu
Univ of California / San Diego Treatment CtrSan Diego, United States
Suspendu
Univ of MinnesotaMinneapolis, United States

Terminé11 Centres d'Étude