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
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of May 11, 2025
Completed
Keywords
ClinConnect Summary
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 AC...
Gender
ALL
Eligibility 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.
About National Institute Of Allergy And Infectious Diseases (Niaid)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Minneapolis, Minnesota, United States
Chapel Hill, North Carolina, United States
Greensboro, North Carolina, United States
Seattle, Washington, United States
Worcester, Massachusetts, United States
Patients applied
Trial Officials
Collier AC
Study Chair
Hirsch M
Study Chair
Corey L
Study Chair
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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