Terminé

A Study of Zidovudine Plus Acyclovir in HIV-Infected Patients

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Ce qui est testé

Zidovudine

+ Acyclovir
Médicament
Qui peut participer

HIV Infections

À partir de 19 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 : 4 novembre 2021
Issu d'une base de données validée par les autorités. Revendiquer cette étude

To compare the effect of zidovudine (AZT) given alone with the combination of AZT and acyclovir (ACV) on the human immunodeficiency virus (HIV) in persons infected with HIV, and to study the pharmacokinetics (how fast AZT reaches certain levels in blood and how long it remains), safety, and effectiveness of AZT given alone and in combination with ACV in treating HIV-infected patients. 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. 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.

Titre officielAn Uncontrolled Trial to Evaluate the Pharmacokinetics and Pharmacodynamics of Zidovudine (AZT) and Acyclovir (ACV) Given Concomitantly to Patients With Human Immunodeficiency Virus Infection 
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 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
72 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 la nature du traitement est tenue confidentielle
Dans une étude en ouvert, tous les participants ainsi que les chercheurs savent quel traitement est administré. Ce type de protocole est utilisé lorsqu'il n'est pas nécessaire ou pas possible de masquer les traitements.

Autres méthodes de masquage
Simple aveugle
: les participants ignorent le traitement reçu, mais les chercheurs le connaissent.

Double aveugle
: ni les participants ni les chercheurs ne savent quel traitement est administré.

Triple aveugle
: Les participants, les chercheurs et les personnes qui analysent les résultats ne savent pas quel traitement est administré.

Quadruple aveugle
: Les participants, les chercheurs, les personnes qui analysent les résultats et les professionnels de santé en charge du suivi ne savent pas non plus quel traitement est administré.

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 19 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

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
Suspendu
Los Angeles County - USC Med CtrLos Angeles, United StatesVoir le site
Suspendu
Univ of California / San Diego Treatment CtrSan Diego, United States
Suspendu
Univ of WashingtonSeattle, United States

Terminé3 Centres d'Étude