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
NCT ID: NCT00000712
Last Updated: 2021-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
400 participants
INTERVENTIONAL
1994-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
PARALLEL
TREATMENT
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Zidovudine
Acyclovir
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
13 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Collier AC
Role: STUDY_CHAIR
Hirsch M
Role: STUDY_CHAIR
Corey L
Role: STUDY_CHAIR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Bmc Actg Crs
Boston, Massachusetts, United States
Beth Israel Deaconess - East Campus A0102 CRS
Boston, Massachusetts, United States
Beth Israel Deaconess Med. Ctr., ACTG CRS
Boston, Massachusetts, United States
Massachusetts General Hospital ACTG CRS
Worcester, Massachusetts, United States
University of Minnesota, ACTU
Minneapolis, Minnesota, United States
Unc Aids Crs
Chapel Hill, North Carolina, United States
Regional Center for Infectious Disease, Wendover Medical Center CRS
Greensboro, North Carolina, United States
University of Washington AIDS CRS
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Collier AC, Schoenfeld DA, Bourland D, Hirsch M, Davis LG, Corey L. Prospective comparative study of acyclovir (ACV) and zidovudine (ZDV) versus ZDV alone in patients with AIDS. Natl Conf Hum Retroviruses Relat Infect (2nd). 1995 Jan 29-Feb 2;125
Ioannidis JP, Collier AC, Cooper DA, Corey L, Fiddian AP, Gazzard BG, Griffiths PD, Contopoulos-Ioannidis DG, Lau J, Pavia AT, Saag MS, Spruance SL, Youle MS. Clinical efficacy of high-dose acyclovir in patients with human immunodeficiency virus infection: a meta-analysis of randomized individual patient data. J Infect Dis. 1998 Aug;178(2):349-59. doi: 10.1086/515621.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
11037
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 063
Identifier Type: -
Identifier Source: org_study_id