Search / Trial NCT00000712

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

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Trial Information

Current as of December 10, 2023

Completed

Keywords

Aids Related Opportunistic Infections Herpesviridae Infections Drug Evaluation Drug Therapy, Combination Herpesvirus 4, Human Cytomegalovirus Infections Acyclovir Acquired Immunodeficiency Syndrome Antiviral Agents Zidovudine

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 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.

Attachments

readout_NCT00000712_2023-12-10.pdf

4.5 MB

NCT00000712_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

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

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
0
Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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