Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 2

A Randomized Trial to Evaluate the Safety and Efficacy of Combination Therapy With Retrovir ( AZT ) and HIVID ( ddC ) Versus Retrovir, HIVID, and Wellferon ( Interferon Alfa-n1 ) for the Treatment of HIV Infection

NCT00002086 · View on ClinicalTrials.gov ↗

Study Summary

Primary: To determine whether the combination of zidovudine/zalcitabine/interferon alfa-n1 (Retrovir/HIVID/Wellferon) can produce complete responses (i.e., CD4 counts return to \>= 800 cells/mm3 for more than 24 weeks) in patients with virus sensitive to all three agents. To determine the antiviral effect of the combination therapies as evidenced by measures of quantitative viral load performed at select study centers only. Secondary: To determine the effectiveness of Retrovir/HIVID and Retrovir/HIVID/Wellferon in maintaining or increasing CD4 counts and preventing disease progression as evidenced by the development of an AIDS-defining indicator disease. To determine the effect of these regimens on secondary measures of clinical status (e.g., performance score, weight change, and secondary infections) and on measures of virologic activity such as serum p24 antigen. To assess the safety and tolerance of these regimens.

Conditions Studied

Interventions

  • DRUG Zidovudine
  • DRUG Zalcitabine
  • DRUG Interferon alfa-n1

Study Locations (13)

California

  • ViRx Inc — San Francisco
  • Marin County Specialty Clinic — San Rafael

Florida

  • Stratogen of South Florida — Miami Beach
  • Univ of South Florida — Tampa

District of Columbia

  • Georgetown Univ Med Ctr — Washington D.C.

Indiana

  • Infectious Diseases Research Clinic / Indiana Univ Hosp — Indianapolis

Kansas

  • Univ of Kansas School of Medicine — Wichita

New York

  • North Shore Univ Hosp / Div of Infectious Diseases — Manhasset

Ohio

  • Univ of Cincinnati — Cincinnati

Oregon

  • Portland Veterans Adm Med Ctr / Rsch & Education Grp — Portland

Trial Details

FieldValue
Enrollment Target 256 participants
Phase Phase 2

Sponsor

Glaxo Wellcome

18 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00002086

The ClinicalTrials.gov registry entry for NCT00002086 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 256 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Glaxo Wellcome, which has 18 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 3 interventions — of which Zidovudine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00002086 reports 13 study locations spanning 11 distinct geographic areas — top geographies include California, Florida, District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00002086 about?

NCT00002086 is a clinical study titled "A Randomized Trial to Evaluate the Safety and Efficacy of Combination Therapy With Retrovir ( AZT ) and HIVID ( ddC ) Versus Retrovir, HIVID, and Wellferon ( Interferon Alfa-n1 ) for the Treatment of HIV Infection". Primary: To determine whether the combination of zidovudine/zalcitabine/interferon alfa-n1 (Retrovir/HIVID/Wellferon) can produce complete responses (i.e., CD4 counts return to \>= 800 cells/mm3 for more than 24 weeks) in patients with virus sensitive to all three agents. To determine the antiviral ...

What is the current status of trial NCT00002086?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 256 participants.

What conditions does trial NCT00002086 study?

This clinical trial studies the following conditions: HIV Infections. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00002086?

The interventions under investigation include: Zidovudine (DRUG), Zalcitabine (DRUG), Interferon alfa-n1 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00002086?

This trial is sponsored by Glaxo Wellcome, which has 18 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00002086 being conducted?

This trial has 13 study locations across California, District of Columbia, Florida, Indiana, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial