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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 Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on 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 conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. 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 Clinical research trials and 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 healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including 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. 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 Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a 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 clinical trial. Test subjects oftentimes recieve the best healthcare possible for their 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 condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > 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  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
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
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Parallel Assignment
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 400
Location and Contact Information:
Overall Study Official:
CollierAC, Study Chair,
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Retrovir Study Ctr
Houston, Texas, 77004
United States
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
Boston Med Ctr
Boston, Massachusetts, 02118
United States
Community Clinic for AIDS Research
Dallas, Texas, 75219
United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
United States
Louisiana State Univ Med Ctr / Tulane Med School
New Orleans, Louisiana, 70112
United States
Bowman Gray School of Medicine / Wake Forest Univ
Winston Salem, North Carolina, 27103
United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
Moses H Cone Memorial Hosp
Greensboro, North Carolina, 27401
United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112
United States
Univ of Missouri at Kansas City School of Medicine
Kansas City, Missouri, 64108
United States
Univ of Nebraska Med Ctr
Omaha, Nebraska, 68198
United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
Wake Med Ctr / Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Saint Luke's - Roosevelt Hosp Ctr
New York City, New York, 10025
United States
Univ of Washington
Seattle, Washington, 981224304
United States
Vanderbilt Univ Hosp
Nashville, Tennessee, 372322605
United States
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, 01655
United States
Additional Information:
Study ID Numbers: ACTG 063;
Study Start Date:
Record last reviewed: December 1994
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000712
Other Hiv Infections Studies:
1. A Study to Evaluate the Safety and Tolerance of Combination Anti-HIV Drug Therapy (Indinavir, Lamivudine, and Zidovudine) in HIV-Positive Pregnant Women and Their Infants
2. A Compassionate Use Study of Tenofovir Disoproxil Fumarate as Treatment for HIV Infection
3. Growth Hormone in the Treatment of HIV-Associated Wasting
4. A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 200 mcg of gp120 (CHO) BIOCINE in MF59 Emulsion Versus the Emulsion Control: Three Injections at 0, 1, and 6 Months
5. Two-Stage Tuberculin (PPD) Skin Testing in Individuals With Human Immunodeficiency Virus (HIV) Infection
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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
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