Terminé

A Phase I/II, Open Label Study to Evaluate the Antiviral Potential of Combination Zidovudine and 2' 3'-Dideoxyinosine (Didanosine) in Patients With Asymptomatic HIV Disease

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Ce qui est testé

Zidovudine

+ Didanosine
Médicament
Qui peut participer

HIV Infections

À partir de 12 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 assess the safety and to evaluate the anti-HIV effect of low-, moderate-, and high-dose schedules of zidovudine (AZT) plus didanosine (ddI) versus ddI alone in asymptomatic HIV-infected patients. Because of the failure with long-term (more than 1 year) use of, frequency of toxicity from, and drug resistance to AZT, drug combinations need to be developed to enable lower, less toxic doses of AZT to be used and to slow or prevent the development of resistance, while providing at least the same effectiveness. Because of the failure with long-term (more than 1 year) use of, frequency of toxicity from, and drug resistance to AZT, drug combinations need to be developed to enable lower, less toxic doses of AZT to be used and to slow or prevent the development of resistance, while providing at least the same effectiveness. Enrollment during the first 8 weeks of the study is restricted to hemophiliacs and sexual partners of hemophiliacs with asymptomatic HIV disease. After the initial 8 weeks this restriction is lifted. Patients are randomized to one of four treatment arms with dosing of AZT plus ddI or ddI alone.

Titre officielA Phase I/II, Open Label Study to Evaluate the Antiviral Potential of Combination Zidovudine and 2' 3'-Dideoxyinosine (Didanosine) in Patients With Asymptomatic HIV 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
116 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 12 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. * Acute and intermittent therapy with mycostatin and mycelex. * Isoniazid, if no alternative therapy is available. Allowed for up to 2 weeks: * Acyclovir for Herpes infection (withhold didanosine during therapy). * Acute therapy with fluconazole or ketoconazole. Allowed but preferably not on a continuous basis for \> 72 hours: * Acetaminophen. * Ibuprofen. * Nonsteroidal antiinflammatory agents. Patients must be: * HIV antibody positive. * Asymptomatic or have persistent generalized lymphadenopathy. * Diagnosed with one of the listed coagulopathies. * OR Sexual partner of someone with the above criteria. Allowed: * Basal cell carcinoma or in situ carcinoma of the cervix. NOTE: * As of January, 1991 full accrual of patients with prior AZT use has been reached - NOW ACCRUING ONLY THOSE WITH NO PRIOR AZT USE. Hemophilia restriction has been lifted. Prior Medication: Allowed: * Zidovudine (AZT) for a total of = or \< 13 months. NOTE: * As of January, 1991 accrual of these patients was reached, NOW ONLY PATIENTS WITH NO PRIOR AZT. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: * Unexplained temperature \> 38 degrees C for more than 5 consecutive days or on more than 10 days in any 30-day period in the 2 years prior to study entry. * Unexplained diarrhea defined as at least 3 liquid stools/day persisting more than 7 days within 2 years prior to study entry. * Unintentional weight loss of \> 10 pounds or \> 10 percent of usual body weight within 2 years prior to study entry. * Oral hairy leukoplakia at any time prior to study entry. * Recurrent oral candidiasis unrelated to the use of antibiotics within 2 years prior to entry or unrelated to the use of antibiotics within the past 3 months. * Herpes zoster within 2 years prior to study entry. * Seizures within the past 6 months or currently requiring anticonvulsants for control. * Current heart disease. * Current psychological or emotional problems sufficient in the investigator's opinion to prevent adequate compliance with study therapy. * Gout. Concurrent Medication: Excluded: * Rifampin. * Chemoprophylaxis for Pneumocystis carinii pneumonia other than aerosolized pentamidine. * Intravenous pentamidine. * Other antiretroviral agents, experimental medication, biological response modifiers, systemic corticosteroids, cimetidine, and ranitidine. * Barbiturates. * Oral acidifying agents. Patients with a history of any of the following are excluded: * AIDS-defining opportunistic infection, advanced AIDS-related complex, or malignancy. * Acute or chronic pancreatitis. * Grade 2 or higher neuropathy based on the Neuropathy Targeted Symptom Questionnaire. * Seizures. * Zidovudine therapy for = or \> 13 months. * Heart disease. * Psychological or emotional problems sufficient in the investigator's opinion to prevent adequate compliance with study therapy. * Gout. Prior Medication: Excluded within 4 weeks of study entry: * Antiretroviral agents, including ribavirin, HPA-23, rifampin, AL721. * Excluded within 3 months of study entry: * Significant course of immunomodulating agents, such as steroids (\> 1 week), isoprinosine, thymic factors, or any other experimental drugs. * Excluded within 30 days prior to study entry: * Neurotoxic drugs. Excluded: * Didanosine (ddI). * Dideoxycytidine (ddC). * Zidovudine (AZT) if received for \> 13 months. Prior Treatment: Excluded within 3 months of entry: * Other experimental therapy. History of recent alcohol abuse.



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 5 sites
Suspendu
Palo Alto Veterans Adm Med Ctr / Stanford UnivPalo Alto, United StatesVoir le site
Suspendu
Whitman - Walker ClinicWashington, United States
Suspendu
Univ of PittsburghPittsburgh, United States
Suspendu
Univ of Pittsburgh Med SchoolPittsburgh, United States

Terminé5 Centres d'Étude