Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
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
This study has been completed.
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000712
  Purpose

Original design: The study's purpose is to compare the effects of zidovudine (AZT) alone to the combination of AZT and acyclovir (ACV) to determine if AZT/ACV is associated with a lower death rate and fewer AIDS related opportunistic infections compared to AZT alone, and to investigate the effect of these treatment plans on cytomegalovirus (CMV) and Epstein-Barr virus (EBV) infections. The study evaluates two doses of AZT used alone versus two doses of AZT combined with ACV. Per 12/11/92 amendment: Another antiretroviral agent may be substituted for AZT.

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.


Condition Intervention Phase
HIV Infections
Drug: Zidovudine
Drug: Acyclovir
Phase II

MedlinePlus related topics: AIDS Cytomegalovirus Infections
Drug Information available for: Zidovudine Acyclovir Acyclovir sodium
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Parallel Assignment
Official Title: 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

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 400
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000712

Locations
United States, District of Columbia
George Washington Univ Med Ctr
Washington, District of Columbia, United States, 20037
United States, Louisiana
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, United States, 70112
Louisiana State Univ Med Ctr / Tulane Med School
New Orleans, Louisiana, United States, 70112
Tulane Univ School of Medicine
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, United States, 02215
Beth Israel Deaconess - West Campus
Boston, Massachusetts, United States, 02215
Boston Med Ctr
Boston, Massachusetts, United States, 02118
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, United States, 01655
United States, Minnesota
Univ of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Univ of Missouri at Kansas City School of Medicine
Kansas City, Missouri, United States, 64108
United States, Nebraska
Univ of Nebraska Med Ctr
Omaha, Nebraska, United States, 68198
United States, New York
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, United States, 10025
United States, North Carolina
Wake Med Ctr / Univ of North Carolina
Chapel Hill, North Carolina, United States, 275997215
Univ of North Carolina
Chapel Hill, North Carolina, United States, 275997215
Moses H Cone Memorial Hosp
Greensboro, North Carolina, United States, 27401
Bowman Gray School of Medicine / Wake Forest Univ
Winston-Salem, North Carolina, United States, 27103
United States, Tennessee
Vanderbilt Univ Hosp
Nashville, Tennessee, United States, 372322605
United States, Texas
Retrovir Study Ctr
Houston, Texas, United States, 77004
Community Clinic for AIDS Research
Dallas, Texas, United States, 75219
United States, Washington
Univ of Washington
Seattle, Washington, United States, 981224304
Sponsors and Collaborators
Investigators
Study Chair: Collier AC
Study Chair: Hirsch M
Study Chair: Corey L
  More Information

Click here for more information about Zidovudine  This link exits the ClinicalTrials.gov site
Click here for more information about Acyclovir  This link exits the ClinicalTrials.gov site

Publications:
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.

Study ID Numbers: ACTG 063
Study First Received: November 2, 1999
Last Updated: July 14, 2008
ClinicalTrials.gov Identifier: NCT00000712  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
AIDS-Related Opportunistic Infections
Herpesviridae Infections
Drug Evaluation
Drug Therapy, Combination
Herpesvirus 4, Human
Cytomegalovirus Infections
Acyclovir
Acquired Immunodeficiency Syndrome
Antiviral Agents
Zidovudine

Study placed in the following topic categories:
Opportunistic Infections
Sexually Transmitted Diseases, Viral
Acquired Immunodeficiency Syndrome
Zidovudine
Cytomegalovirus
Immunologic Deficiency Syndromes
Herpesviridae Infections
Virus Diseases
Acyclovir
HIV Infections
AIDS-Related Opportunistic Infections
Sexually Transmitted Diseases
Cytomegalovirus Infections
Retroviridae Infections
Cytomegalic inclusion disease

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009