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

NCT01125228 | Active Not Recruiting

• 2 other identifiers: 88017288-I-0172
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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

HIV

Keywords

HIV; Natural History

Outcome Measures

Primary Outcomes (2)

• Long term follow up

  long-term follow-up of the medical and treatment outcomes of patients who received anti-HIV treatment and alpha-IFN in the pre-HAART era

  ongoing

• sample collection

  Ongoing prospective research plasma and cell collection as new lab assays and study questions continue to emerge (especially regarding immune activation and the pathways that drive it).

  ongoing

Study Arms (3)

AZT Alone

Zidovudine 200mg by mouth every 4hr

Drug: Ziodovudine and Alpha Interferon

AZT plus IFN

-Zidovudine 200mg by mouth every 4hr -Alpha Interferon 1 million units once a day, escalating

Drug: Ziodovudine and Alpha Interferon

IFN Alone

-Alpha Interferon 1 million units once a day, escalating

Interventions

Ziodovudine and Alpha Interferon DRUG

AZT Alone; AZT plus IFN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals infected with HIV during the 1980s and living throughout the US

You may qualify if:

• Over 18 years of age.
• T4 lymphocyte count greater than or equal to 500/mm3.
• Infection with HIV as documented by positive ELISA and Western blot and positive HIV culture or positive p24 antigen or positive polymerase chain reaction.
• Absence of current opportunistic infection (defined for purposes of this study as: candidiasis, cryptosporidiosis, mycobacterial infection, persistent herpes simplex infection, isosporiasis, cytomegalovirus infection, toxoplasmosis, pneumocystosis, salmonellosis, and cryptococcosis). Routine clinical methods and observations were performed to exclude such patients.
• Afebrile (Temperature less the 38 degrees Centigrade orally) without antipyretics for at least 72 hours prior to enrollment.
• Performance status 0, 1, or 2.
• Relatively stable clinical condition, with no deterioration of performance status in the month prior to enrollment.
• Ability to give informed consent and willing to comply with all procedures and visits scheduled.
• Suitability of I.V. access for the scheduled blood tests.
• Normal renal function as defined by BUN less than or equal to 30 and creatinine less than or equal to 1.5.
• Normal hepatic function with transaminases and alkaline phosphatase less than 5 times the upper limit of normal range.
• Hemoglobin greater than or equal to 10 gm/dl, total granulocyte count greater than or equal to 1250/mm(3), platelet count greater than or equal to 125,000/mm(3).
• No previous therapy for KS within the month prior to enrollment, and no prior exposure to investigational agents. Prior exposure to AZT did not disqualify a patient; however patients were stratified on this basis.

You may not qualify if:

• Patients with malignancy other than Kaposi's sarcoma were specifically excluded from this study.
• Pregnant women, nursing mothers, or women of childbearing potential who were not employing effective means of contraception or abstinence.
• Patients actively using illicit drugs.
• Patients receiving systemically and potentially myelosuppressive drugs (such as TMP/SMX, pyrimethamine-sulfa or DHPG), nephrotoxic agents (such as amphotericin B or aminoglycosides), or cytotoxic or experimental chemotherapy.
• Patients with a history of significant depressive disorder.
• Patients with a history of an AIDS-defining opportunistic infection.
• After enrollment, a patient was excluded from further participation in the study for any of the following reasons:
• Serious infection not cleared by antibiotic therapy. The occurrence of a life-threatening infection, whether or not considered to be opportunistic, will prompt a discontinuation of therapy during the infection and for 2 weeks following its successful resolution. Therapy was re-initiated unless (1) in the investigator's judgment re-treatment with either or both of the study medications would be contraindicated for other reasons or (2) therapy had been held for more than 6 weeks.
• Decrease in percent CD4 to less than 20 percent or in absolute CD4 count to less than 200/mm(3) on 3 consecutive blood tests.
• Systemic allergic reaction to either study medication, characterized by angioedema, bronchial constriction, or anaphylaxis.
• It was the principal investigator's judgment that the patient was too ill to continue in the trial.
• Toxicity necessitating withdrawal.
• Patient non-compliance: A patient not taking medication as directed or not keeping appointments was not allowed to continue on this study.
• Rapid or life-threatening progression of KS such that the principal investigator believed other therapies would be in the patient's best interest.
• Voluntary withdrawal: A patient could remove himself from study at any time. The patient was allowed to withdraw without prejudice.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Interventions

Interferon-alpha

Intervention Hierarchy (Ancestors)

Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Mary E Wright, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2010
• First Posted: May 18, 2010
• Study Start: October 19, 1988
• Last Updated: June 3, 2026

Record last verified: 2025-08-19

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: From start of study to present.
• Access Criteria: Requests will be evaluated by the PI. Data will be shared if related to protocol objectives and will occur through encrypted, secure platforms. For NIH or outside investigator requests not related to protocol objectives, IRB approval will be required.

Locations

US (1)