A Multicenter, Double Blind, Comparative Study of Zidovudine Alone Versus Zidovudine and Acyclovir as Treatment for HIV-Infected Patients With CD4+ Counts Less Than 200 Cells/mm3
Data Collection
Blood-Borne Infections+20
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
AZT has been shown to increase the life span of patients with AIDS or advanced AIDS related complex and patients being treated for Pneumocystis carinii pneumonia. Drugs that increase the effectiveness of AZT against HIV may also decrease the need for high doses of AZT. This might reduce some of the negative effects of AZT while not reducing the positive effects. AMENDED: Patients are randomly assigned to one of two treatment regimens. They receive AZT (or other antiretroviral agent) with or without ACV. Treatment Plan 1: AZT along with placebo at the same time. Treatment Plan 2: AZT and ACV. Therapy is for 104 weeks with an optional extension of 24 weeks or until the end of the study whichever comes first. The maximum duration of therapy for any patient will be 128 weeks. Medication is dispensed on a biweekly basis for the first 4 weeks, then every other month for the remainder of the study. Original design: Patients are randomly assigned to one of four treatment plans to receive AZT alone or AZT and ACV. Medications are given every 4 hours (q4h) orally (PO) while awake (WA). A total of 5 doses/day are given. The per dose schedule for the four plans are: Treatment plan 1: AZT plus placebo (an inactive medication) substituting for ACV. Treatment plan 2: AZT and AZT placebo along with an ACV placebo. Treatment plan 3: AZT and ACV. Treatment plan 4: AZT and AZT placebo and ACV.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.400 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 13 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria Concurrent Medication: Allowed: * Methadone maintenance. Therapies available through expanded access or treatment IND programs unless specifically excluded. * Allowed within 30 days of study entry: * Systemic steroids only if given for treatment of Pneumocystis carinii pneumonia. * Recommended: * PCP prophylaxis. Patient must have: * Recovered from first episode of histologically proven Pneumocystis carinii pneumonia (PCP) or microbiologically proven AIDS-defining opportunistic infection as defined in Centers for Disease Control HIV classification group IV. * C-1. * Study entry must be within 120 days of AIDS-defining diagnosis. * Written documentation of positive antibody to HIV by any federally licensed ELISA test kit. This test should be confirmed by another method, for example, Western blot, radioimmunoassay (RIA), HIV culture. * Patients cannot be transfusion dependent (requiring blood transfusion more than once per month). The last transfusion must be \> 2 weeks before entry. * AMENDED 90-08-27 to include HIV positive patients with CD4+ count \< 200 cells/mm3. Prior Medication: Allowed: * Zidovudine (AZT) for \< 365 days prior to study entry. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: * Symptomatic visceral or progressive Kaposi's sarcoma (KS) (defined by \> 10 new lesions in the 30 days prior to entry). * Other concurrent neoplasms other than basal cell carcinoma of skin (patients who have been in complete remission for 1 year for a malignancy may be enrolled). * Malabsorption as defined by persistent diarrhea \> 6 stools/day for \> 4 weeks. Patients whose sole AIDS-defining condition is constitutional disease as defined in CDC's HIV group IV-A or neurologic disease as defined in CDC's HIV group IV-B or AIDS-associated malignancies as defined in CDC's HIV group IV-C. Concurrent Medication: Excluded: * Acyclovir (ACV) prophylaxis or frequent (\> once per month) repeated courses of ACV therapy for herpes simplex virus infection. * Any concomitant medicine unless required. * Systemic therapy/prophylaxis/maintenance for AIDS-defining opportunistic infection other than prophylaxis for Pneumocystis carinii pneumonia (PCP). * Acetaminophen for \> 72 hours. Cimetidine. * Flurazepam. * Indomethacin. * Ranitidine. * Probenecid (if receiving AZT). * Rifampin. * Rifampin-related drugs. Patients with the following are excluded: * Active opportunistic infections. * Symptomatic visceral or progressive Kaposi's sarcoma (KS) (defined by \> 10 new lesions in the 30 days prior to entry). * Other concurrent neoplasms other than basal cell carcinoma of skin (patients who have been in complete remission for 1 year for a malignancy may be enrolled). * Malabsorption as defined by persistent diarrhea \> 6 stools/day for \> 4 weeks. * Patients whose sole AIDS-defining condition is constitutional disease as defined in CDC's HIV group IV-A or neurologic disease as defined in CDC's HIV group IV-B or AIDS-associated malignancies as defined in CDC's HIV group IV-C. Prior Medication: Excluded: * Zidovudine (AZT) for \> 365 days prior to study entry. * Excluded within 14 days of study entry: * Systemic acyclovir (ACV) therapy. * Excluded within 30 days of study entry: * Antiretroviral therapy (other than AZT per above). * Immunomodulating agents. * Biologic response modifiers. Excluded within 60 days of study entry: * Ribavirin. Prior Treatment: Excluded within 30 days of study entry: * Cytotoxic chemotherapy or radiation therapy for Kaposi's sarcoma. Active substance abuse that would impair compliance with study procedure.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 8 locations
Beth Israel Deaconess - East Campus A0102 CRS
Boston, United StatesBeth Israel Deaconess Med. Ctr., ACTG CRS
Boston, United StatesMassachusetts General Hospital ACTG CRS
Worcester, United States