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NCT00002086 · ClinicalTrials.gov registry record · 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
A Phase 2 study of HIV Infections, sponsored by Glaxo Wellcome.
- Completed
- Registry status
- Phase 2
- Development phase
- 256
- Enrollment target
- 13
- Study locations
NCT00002086 is a Phase 2 study of HIV Infections that has completed, run by Glaxo Wellcome. The registered enrollment target is 256 participants, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (42% lower). The trial reports 13 study locations across 11 states.
The verdict
NCT00002086, a Phase 2 study of HIV Infections, has completed, sponsored by Glaxo Wellcome.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 256 participants
- Enrollment target
- 13
- Study locations
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
| Field | Value |
|---|---|
| Enrollment Target | 256 participants |
| Phase | Phase 2 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 256 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (42% lower). The listed sponsor is Glaxo Wellcome, which has 65 total studies on file at ClinicalTrials.gov.
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.
NCT00002086 reports 13 study locations spanning 11 distinct geographic areas - top geographies include California, Florida, District of Columbia.
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.
What interventions are being tested in trial NCT00002086?
The interventions under investigation include: Zidovudine (DRUG), Zalcitabine (DRUG), Interferon alfa-n1 (DRUG).
Who is sponsoring clinical trial NCT00002086?
This trial is sponsored by Glaxo Wellcome, which has 65 total clinical trials registered on ClinicalTrials.gov.
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.
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Related
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