A Multi-Center, Double-Blind Trial to Evaluate the Safety and Efficacy of Concurrent Retrovir (Zidovudine) and Zovirax (Acyclovir) Therapy in Patients With Early Symptomatic Human Immunodeficiency Virus (HIV) Infection
Zidovudine
+ Acyclovir
Infections transmises par le sang+15
+ Maladies génito-urinaires
+ Maladies Génitales
Étude thérapeutique
Résumé
This double-blind, placebo-controlled study is designed to determine the long-term safety and efficacy of concurrent oral Retrovir / Zovirax (AZT and ACV) therapy and oral AZT therapy alone, in the treatment of early symptomatic HIV infection. Efficacy will be evaluated by monitoring the incidence, severity, and time of development of opportunistic infections and other manifestations of advanced symptomatic HIV infection. The effects of the combination and single AZT therapy on immune function and viral replication will also be evaluated. Study participants will be monitored for evidence of toxicity or intolerance to concurrent AZT / ACV administration and AZT therapy alone.
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.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 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
Critères
Inclusion Criteria Patients must have: Early AIDS related complex (ARC). Willingness to be followed by the original study center for the duration of the trial (96 weeks). Ability to give informed consent. Patients may have associated lymphadenopathy (lymph nodes greater than or equal to 1 cm in two noncontiguous areas). Exclusion Criteria Co-existing Condition: Patients with the following are excluded: Concurrent neoplasms other than basal cell carcinoma of the skin or in situ carcinoma of the cervix. Fever > 102 degrees F persisting for more than 14 consecutive days or more than 15 days in a 30-day interval, present at entry. Severe malabsorption (evidenced by persistent diarrhea of greater than 4 weeks duration with = or > 6 loose stools per day accompanied by significant weight loss). Concurrent Medication: Excluded: Acyclovir (ACV) therapy for chronic or recurrent herpes simplex. Patients with an AIDS-defining indicator disease as outlined by the CDC surveillance definition for AIDS which includes opportunistic infections or neoplasms, HIV neurologic disease, AIDS dementia or the "wasting syndrome" are excluded. Prior Medication: Excluded within 4 weeks of study entry: Any other experimental therapy. Drugs which cause significant bone marrow suppression. Rifampin or rifampin derivatives. Cytolytic chemotherapy. Drugs which cause significant nephrotoxicity or hepatotoxicity. Immunomodulating agents, including steroids, interferon, Isoprinosine, immunoglobulin or interleukin 2. Excluded within 8 weeks of study entry: Antiretroviral agents.
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 14 sites
Birmingham Veterans Administration Med Ctr / Univ of Alabama
Birmingham, United StatesOuvrir Birmingham Veterans Administration Med Ctr / Univ of Alabama dans Google MapsUniv of Arizona / Health Science Ctr
Tucson, United StatesViRx Inc
San Francisco, United StatesGeorgetown Univ Med Ctr / Main Hosp 4
Washington D.C., United States