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Effectiveness of Zidovudine vs. Zidovudine Plus Alpha Interferon vs. Interferon for Treatment of HIV

NCT01125228 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 180

Last updated 2026-04-29

No results posted yet for this study

Summary

This study will compare the effectiveness of zidovudine (AZT) alone vs. zidovudine plus interferon (IFN) vs. interferon alone in reducing HIV viral load, lessening immune system deterioration, and increasing the time to development of the first opportunistic infection in HIV-infected patients.

HIV-infected persons 18 years of age and older with a T4 lymphocyte count of 500/mm3 or more and no current opportunistic infections may be eligible for this study. Candidates will be screened with a medical history, physical examination, blood tests, chest X-ray, electrocardiogram, urinalysis, and, for patients with Kaposi s sarcoma lesions, measurement, photographs, and biopsy of lesions.

Patients will be assigned to receive treatment with either zidovudine alone, zidovudine plus interferon or interferon alone. They will continue treatment until one of the following occurs:

* Unacceptable side effects, despite dose modifications
* Development of an opportunistic infection
* Decrease in CD4 count by 20 percent or to an absolute count of less than 200/mm3
* Rapid progression of Kaposi s sarcoma lesions, requiring alternative therapy
* A decision is made to terminate the study

Patients will be followed long term for viral load, immune function, development of opportunistic infections, disease progression, and survival.

Conditions

Interventions

DRUG

Ziodovudine and Alpha Interferon

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Mary E Wright, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1988-10-19

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01125228 on ClinicalTrials.gov