A Multi-Center Clinical Trial To Evaluate Azidothymidine (AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Infection in Patients With AIDS Post First Episode PCP
To examine the dose of zidovudine (AZT) that was used in the first placebo-controlled study of AZT in AIDS patients as well as a lower dose of AZT in order to determine if the lower dose results in less harmful side effects while still being effective. Previous studies have shown the effectiveness of AZT in AIDS therapy. AZT has been effective in test tube studies at varying doses. There is a...
Brief Summary
Official Title: “A Multi-Center Clinical Trial To Evaluate Azidothymidine (AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Infection in Patients With AIDS Post First Episode PCP”
To examine the dose of zidovudine (AZT) that was used in the first placebo-controlled study of AZT in AIDS patients as well as a lower dose of AZT in order to determine if the lower dose results in less harmful side effects while still being effective. Previous studies have shown the effectiveness of AZT in AIDS therapy. AZT has been effective in test tube studies at varying doses. There is a need to see if lower doses result in effective therapy with less harmful side effects.
- Study Type: Interventional
- Study Design: Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment
Detailed Clinical Trial Description
Previous studies have shown the effectiveness of AZT in AIDS therapy. AZT has been effective in test tube studies at varying doses. There is a need to see if lower doses result in effective therapy with less harmful side effects.
Patients are assigned at random to one of two treatment programs: (1) 1 dose of AZT given orally (PO) for 6 doses per day; (2) 2 doses of AZT PO for 4 weeks followed by 1 dose PO for the remainder of the trial.
Intervention(s) in this Clinical Trial
- Drug: Zidovudine
Criteria for Participation in this Clinical Trial
Inclusion Criteria
Concurrent Medication:
Allowed:
- All concomitant medication to minimum and record.
- Any approved medications can be used to treat an opportunistic infection.
- Dapsone may be used for Pneumocystis carinii pneumonia (PCP).
- Pyrimethamine - sulfadoxine may be used for toxoplasmosis.
- Ganciclovir for cytomegalovirus may be used for maintenance only.
- Prophylactic therapy for PCP.
Concurrent Treatment:
Allowed:
- Local, limited radiation therapy to isolated Kaposi's sarcoma lesions provided total area is < 5 x 5 cm and a 6-MeV electron beam or 90 kV x-ray = or < 3000 rads total is used.
Patients must have:
- HIV seropositivity as confirmed by any federally licensed ELISA test kit.
- Allowed:
- Malignancy in past which has been in complete remission for 1 year without therapy.
Exclusion Criteria
Co-existing Condition:
- Patients with active opportunistic infections will be excluded.
Concurrent Medication:
Excluded:
- Aspirin on a regular basis or beyond 72 hours without contacting investigator.
- Cimetidine.
- Flurazepam.
- Indomethacin.
- Ranitidine.
- Probenecid.
Patients with the following are excluded:
- Status post-Pneumocystis carinii pneumonia with symptomatic visceral Kaposi's sarcoma (KS) or progression of KS within the month prior to study entry.
- Other concurrent neoplasms other than basal cell carcinoma of the skin.
- Requiring blood transfusions > once per month. Last transfusion cannot have been given within 7 days of entry.
- Active substance abuse. Unwilling to sign informed consent or to be followed at medical center where enrolled for duration of study and follow-up if necessary.
Prior Medication:
Excluded within 2 weeks of study entry:
- Treatment for acute Pneumocystis carinii pneumonia (PCP).
- Excluded within 30 days of study entry:
- Other antiretroviral agents, immunomodulating agents, or corticosteroids.
Prior Treatment:
Excluded within 30 days of study entry:
- Radiation therapy or cytotoxic chemotherapy for Kaposi's sarcoma.
Required:
- Patients must be at least 2 weeks post- therapy status for acute Pneumocystis carinii pneumonia (PCP).
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 12 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: National Institute of Allergy and Infectious Diseases (NIAID) NIH
Overall Clinical Trial Officials and Contacts
Fischl M Study Chair
Related Publications
References
Fischl M, Parker CB, Pettinelli C, Wulfsohn M, Rasheed S. The efficacy and safety of a lower dose of zidovudine in the treatment of patients with AIDS-associated PCP. Int Conf AIDS. 1990 Jun 20-23;6(1):138 (abstract no ThB20)
De Gruttola V, Wulfsohn M, Fischl MA, Tsiatis A. Modeling the relationship between survival and CD4 lymphocytes in patients with AIDS and AIDS-related complex. J Acquir Immune Defic Syndr. 1993 Apr;6(4):359-65.
McMahon DK, Winkelstein A, Armstrong JA, Pazin GJ, Hawk H, Ho M. Zidovudine therapy is associated with an increased capacity of phytohemagglutinin-stimulated cells to express interleukin-2 receptors. Pittsburgh AIDS Clinical Trial Unit. AIDS. 1991 May;5(5):491-6.
Richman DD, Grimes JM, Lagakos SW. Effect of stage of disease and drug dose on zidovudine susceptibilities of isolates of human immunodeficiency virus. J Acquir Immune Defic Syndr. 1990;3(8):743-6.
Wulfsohn M, Fischl M, Tsiatis A. Predictors of survival among patients with AIDS receiving zidovudine. Int Conf AIDS. 1992 Jul 19-24;8(2):C314 (abstract no PoC 4419)
Rinaldo C, Huang XL, Piazza P, Armstrong J, Rappocciolo G, Pazin G, McMahon D, Gupta P, Fan Z, Zhang Z, et al. Augmentation of cellular immune function during the early phase of zidovudine treatment of AIDS patients. J Infect Dis. 1991 Oct;164(4):638-45.
Fischl MA, Parker CB, Pettinelli C, Wulfsohn M, Hirsch MS, Collier AC, Antoniskis D, Ho M, Richman DD, Fuchs E, et al. A randomized controlled trial of a reduced daily dose of zidovudine in patients with the acquired immunodeficiency syndrome. The AIDS Clinical Trials Group. N Engl J Med. 1990 Oct 11;323(15):1009-14.
Unadkat JD, Collier AC, Crosby SS, Cummings D, Opheim KE, Corey L. Pharmacokinetics of oral zidovudine (azidothymidine) in patients with AIDS when administered with and without a high-fat meal. AIDS. 1990 Mar;4(3):229-32.
Coombs RW, Collier AC, Allain JP, Nikora B, Leuther M, Gjerset GF, Corey L. Plasma viremia in human immunodeficiency virus infection. N Engl J Med. 1989 Dec 14;321(24):1626-31.
Winkelstein A, McMahon D, Hawk H, Armstrong JA, Pazin GJ, Ho M. AZT therapy is associated with an increased capacity of PHA-stimulated cells to express IL-2 receptors (IL-2R). Int Conf AIDS. 1989 Jun 4-9;5:281 (abstract no MBP355)
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00000700
Study ID Number: ACTG 002
ClinicalTrials.gov Identifier: NCT00000700
Health Authority: United States: Federal Government
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