Terminé

An Uncontrolled Trial to Evaluate the Pharmacokinetics and Pharmacodynamics of Zidovudine (AZT) and Acyclovir (ACV) Given Concomitantly to Patients With Human Immunodeficiency Virus Infection

0 critères remplis à partir de votre profilVoyez en un coup d'œil comment votre profil répond à chaque critère d'éligibilité.
Ce qui est testé

Zidovudine

+ Acyclovir

Médicament
Qui peut participer

Infections transmises par le sang+14

+ Maladies génito-urinaires

+ Maladies Génitales

À partir de 19 ans
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Étude thérapeutique

Phase 1
Interventionnel
Voir le détail du protocole

Résumé

Sponsor principalNational Institute of Allergy and Infectious Diseases (NIAID)
Dernière mise à jour : 4 novembre 2021
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Other studies have shown that AZT offers potential benefits to specific AIDS patients when given over long time periods, and experiments in vitro (in the test tube) suggest that ACV may stimulate the action of AZT against HIV. It is necessary to obtain information on how these drugs perform in HIV-infected humans. The first 12 patients will take AZT capsules every 4 hours, and 6 of the patients will also take ACV 6 times a day. Later groups of patients will receive higher doses of AZT if the earlier doses are tolerated without significant adverse effect. It was initially planned to stop treatment after 12 weeks, but if the first 10 patients who have entered the study have tolerated treatment well, the duration of treatment will be extended with a crossover in dosage. The treatment may be lifelong, depending on the results obtained with regard to safety and effectiveness of the drugs. Blood and urine samples will be obtained periodically in order to estimate blood levels of the drugs, to study the excretion of the drugs, and to determine the effects of the drugs on HIV and on the immune system and medical condition of the patient.

Sponsor principalNational Institute of Allergy and Infectious Diseases (NIAID)
Dernière mise à jour : 4 novembre 2021
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

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

72 participants à inclure

Nombre 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.

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 sexe

Le sexe biologique des participants éligibles à s'inscrire.

À partir de 19 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains non autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

Infections transmises par le sangMaladies génito-urinairesMaladies GénitalesMaladies TransmissiblesSyndromes de Déficience ImmunologiqueMaladies du Système ImmunitaireInfectionsInfections à RetroviridaeInfections à virus ARNMaladies Sexuellement TransmissiblesMaladies à virus lentMaladies viralesMaladies Sexuellement Transmissibles ViralesInfections à LentivirusSyndrome d'Immunodéficience AcquiseComplexe associé au SIDAInfections à VIH

Critères

Exclusion Criteria Active drug or alcohol abuse. Concurrent Medication: Excluded: Any chronic systemic medications. Aspirin. Cimetidine. Flurazepam. Indomethacin. Ranitidine. Probenecid. Excluded during first 2 weeks of study: Any chronic ( > 3 days) medication. Acetaminophen and other drugs that are metabolized by hepatic glucuronidation. Prior Medication: Excluded: Zidovudine (AZT) at any time. Excluded within 14 days of study entry: Other experimental therapy. Drugs which cause neutropenia or significant nephrotoxicity. Rifampin or rifampin derivatives. Systemic anti-infectives. Excluded within 30 days of study entry: Immunomodulating agents. Excluded within 3 months of study entry: Any antiretroviral agent. Patients may not have any of the following: A gastrointestinal disturbance which may impair oral absorption. Chronic persistent candidiasis. An opportunistic infection or malignancy fulfilling the definition of AIDS-associated disease. Patients with symptoms suggestive of an opportunistic infection should be evaluated within 30 days of starting drug. Patients may not have any of the following: A gastrointestinal disturbance which may impair oral absorption. Chronic persistent candidiasis. An opportunistic infection or malignancy fulfilling the definition of AIDS-associated disease. Patients with symptoms suggestive of an opportunistic infection should be evaluated within 30 days of starting drug. All patients will have positive antibody for HIV confirmed by any federally licensed ELISA test kit; if ELISA is negative, eligibility will be confirmed by a positive Western blot. All patients will have evidence of HIV infection in the plasma as indicated by circulatory p24 antigen within 30 days prior to study entry. The symptomatic HIV infection required for inclusion is defined as at least one of the following: Temperature > 38.0 degrees C persisting for more than 14 consecutive days or more than 15 days in a 30-day interval prior to study entry without definable cause. Diarrhea, defined as = or > 3 liquid stools per day, persisting for more than 1 month prior to entry into the study without definable cause. Weight loss greater than 10 percent of body weight noted in a 120-day period prior to entry into the study. Patients with persistent generalized lymphadenopathy (PGL), defined as lymph node enlargement greater than 1 cm in diameter at two or more noncontiguous extrainguinal sites, who in addition to this adenopathy have constitutional symptoms such as intermittent fever (> 38 degrees C for less than 15 days/month), sweats, malaise, and/or fatigue will also be eligible. This patient population has to have T4 cell counts = or < 500. Potential enrollees with PGL must have two screening lymphocyte subset determinations, at least 72 hours apart, within 3 months of entry that fall in the appropriate T4 range (200 - 500 cells/mm3). If an otherwise eligible subject has one screening T4 count in the appropriate range and one that is outside this range, a third screening count will determine eligibility.

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 3 sites

Los Angeles County - USC Med Ctr

Los Angeles, United StatesOuvrir Los Angeles County - USC Med Ctr dans Google Maps

Univ of California / San Diego Treatment Ctr

San Diego, United States

Univ of Washington

Seattle, United States
Terminé3 Centres d'Étude