Terminé

Suppression of Cytomegalovirus Retinitis Utilizing High Dose Intravenous Acyclovir and Oral Zidovudine in Patients With AIDS

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Ce qui est testé

Zidovudine

+ Acyclovir
Médicament
Qui peut participer

Cytomegalovirus Retinitis

+ HIV Infections
À partir de 13 ans
Comment se déroule l'étude

Étude thérapeutique

Interventionnel

Résumé

Sponsor principalNational Institute of Allergy and Infectious Diseases (NIAID)
Dernière mise à jour : 2 novembre 2021
Issu d'une base de données validée par les autorités. Revendiquer cette étude

To study the use of acyclovir (ACV) and zidovudine (AZT) in the treatment of cytomegalovirus (CMV) retinitis in patients with AIDS who would otherwise be treated with ganciclovir (DHPG) alone. CMV retinitis is one of the most common opportunistic infections in patients with AIDS. DHPG is at present the only drug available for widespread compassionate use in the United States. Although most patients respond to treatment with DHPG, the medication does not cure the infection. Most patients will have a relapse and will require retreatment with DHPG. Because of the large relapse rate, most people treated for CMV retinitis are placed on continuous treatment with DHPG. There are two major problems associated with ongoing use of DHPG: 1) The development of a low white blood cell (WBC) count (leukopenia) which is a known side effect of the drug; and 2) the increased risk for leukopenia when DHPG is given together with AZT, the only antiviral drug currently available for the treatment of HIV infection. Therefore, patients cannot take both AZT and DHPG at the same time because the bone marrow toxicity is made much more severe when the drugs are given together. This has resulted in the difficult decision as to whether to forgo potential life-extending therapy with AZT in order to preserve sight. An effective treatment for CMV retinitis is needed that will allow the patient to also take AZT. ACV is presently the drug of choice for severe herpes virus infections. It has been shown to be effective in suppressing severe CMV disease in patients who have received bone marrow transplants. CMV retinitis is one of the most common opportunistic infections in patients with AIDS. DHPG is at present the only drug available for widespread compassionate use in the United States. Although most patients respond to treatment with DHPG, the medication does not cure the infection. Most patients will have a relapse and will require retreatment with DHPG. Because of the large relapse rate, most people treated for CMV retinitis are placed on continuous treatment with DHPG. There are two major problems associated with ongoing use of DHPG: 1) The development of a low white blood cell (WBC) count (leukopenia) which is a known side effect of the drug; and 2) the increased risk for leukopenia when DHPG is given together with AZT, the only antiviral drug currently available for the treatment of HIV infection. Therefore, patients cannot take both AZT and DHPG at the same time because the bone marrow toxicity is made much more severe when the drugs are given together. This has resulted in the difficult decision as to whether to forgo potential life-extending therapy with AZT in order to preserve sight. An effective treatment for CMV retinitis is needed that will allow the patient to also take AZT. ACV is presently the drug of choice for severe herpes virus infections. It has been shown to be effective in suppressing severe CMV disease in patients who have received bone marrow transplants. Patients receive ACV intravenously and AZT orally for 12 weeks. Tolerance of the combined administration of ACV and AZT is monitored. AMENDED: AZT dose lowered and inclusion of concurrent medication expanded.

Titre officielSuppression of Cytomegalovirus Retinitis Utilizing High Dose Intravenous Acyclovir and Oral Zidovudine in Patients With AIDS 
Sponsor principalNational Institute of Allergy and Infectious Diseases (NIAID)
Dernière mise à jour : 2 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
25 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 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
Cytomegalovirus Retinitis
HIV Infections
Critères

Inclusion Criteria Prior Medication: Required: * Patients must have successfully completed remission induction therapy with ganciclovir (minimum of 14 days of therapy) for acute cytomegalovirus (CMV) retinitis within the preceding 48 hours. Patients who show no evidence of progressive disease are considered to have met criteria for successful induction. Amended to allow: * Investigational triazoles. * Human recombinant erythropoietin (Eprex). * Other investigational non-antiviral therapies offered through treatment IND. Patients must: * Have HIV infection as determined by a commercially licensed ELISA test confirmed by a licensed Western blot * Have salvageable vision (corrected acuity of 20/100 or better) in at least one eye. * Be capable of signing an informed consent. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: * Known or suspected allergy to one of the study medications. * Inability to maintain adequate hydration status. Concurrent Medication: Excluded: * Concurrent therapy with nephrotoxic agents. * Systemic therapy for another opportunistic infection. * Systemic prophylaxis for Pneumocystis carinii pneumonia (PCP). * Probenecid. * Patients are advised that validity of this trial may be jeopardized by use of other potentially antiviral or immunomodulating treatments. Patients with the following are excluded: * Known or suspected allergy to one of the study medications. * Inability to maintain adequate hydration status. Prior Medication: Excluded within 2 weeks of study entry: * Steroids. * Cytotoxic or immunosuppressive drugs. * Investigational agents. (Amended to now allow these.) Immunomodulatory drugs (except ganciclovir). Prior Treatment: Excluded within 2 weeks of study entry: * Radiotherapy. Risk Behavior: Excluded: * History of unreliable drug intake and inability to cooperate in the testing procedures. Unwilling or unable to give informed consent or unwilling to sign approved consent form.



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 2 sites
Suspendu
Northwestern Univ Med SchoolChicago, United StatesVoir le site
Suspendu
Rush Presbyterian - Saint Luke's Med CtrChicago, United States

Terminé2 Centres d'Étude