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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000712 |
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 |
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HIV Infections |
Drug: Zidovudine Drug: Acyclovir |
Phase II |
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 |
Estimated Enrollment: | 400 |
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.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patient must have:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
Concurrent Medication:
Excluded:
Patients with the following are excluded:
Prior Medication:
Excluded:
Excluded within 60 days of study entry:
Prior Treatment:
Excluded within 30 days of study entry:
Active substance abuse that would impair compliance with study procedure.
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 |
Study Chair: | Collier AC | |
Study Chair: | Hirsch M | |
Study Chair: | Corey L |
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 |
AIDS-Related Opportunistic Infections Herpesviridae Infections Drug Evaluation Drug Therapy, Combination Herpesvirus 4, Human |
Cytomegalovirus Infections Acyclovir Acquired Immunodeficiency Syndrome Antiviral Agents Zidovudine |
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 |
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 |