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NCT00000712 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 400
- Enrollment target
- 8
- Study locations
NCT00000712: Completed Phase 2 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00000712 is a Phase 2 study of HIV Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 400 participants, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (10% lower). The trial reports 8 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00000712, a Phase 2 study of HIV Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 400 participants
- Enrollment target
- 8
- Study locations
Study Summary
Original design: The study's purpose is to compare the effects of zidovudine (AZT) alone to the combination of AZT and acyclovir (ACV) to determine if AZT/ACV is associated with a lower death rate and fewer AIDS related opportunistic infections compared to AZT alone, and to investigate the effect of these treatment plans on cytomegalovirus (CMV) and Epstein-Barr virus (EBV) infections. The study evaluates two doses of AZT used alone versus two doses of AZT combined with ACV. Per 12/11/92 amendment: Another antiretroviral agent may be substituted for AZT. 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.
Conditions Studied
Interventions
- DRUG Zidovudine
- DRUG Acyclovir
Study Locations (8)
Massachusetts
- Bmc Actg Crs - Boston
- Beth Israel Deaconess - East Campus A0102 CRS - Boston
- Beth Israel Deaconess Med. Ctr., ACTG CRS - Boston
- Massachusetts General Hospital ACTG CRS - Worcester
North Carolina
- Unc Aids Crs - Chapel Hill
- Regional Center for Infectious Disease, Wendover Medical Center CRS - Greensboro
Minnesota
- University of Minnesota, ACTU - Minneapolis
Washington
- University of Washington AIDS CRS - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Est. Completion | 1994-11 |
| Phase | Phase 2 |
What the finished NCT00000712 record still lists
NCT00000712 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (10% lower).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which Zidovudine is the first listed.
NCT00000712 lists 8 locations in 4 states (Massachusetts, North Carolina, Minnesota).
Frequently Asked Questions
What is clinical trial NCT00000712 about?
NCT00000712 is a clinical study titled "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". Original design: The study's purpose is to compare the effects of zidovudine (AZT) alone to the combination of AZT and acyclovir (ACV) to determine if AZT/ACV is associated with a lower death rate and fewer AIDS related opportunistic infections compared to AZT alone, and to investigate the effect of...
What is the current status of trial NCT00000712?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 400 participants. Estimated completion is 1994-11.
What conditions does trial NCT00000712 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT00000712?
The interventions under investigation include: Zidovudine (DRUG), Acyclovir (DRUG).
Who is sponsoring clinical trial NCT00000712?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00000712 being conducted?
This trial has 8 study locations across Massachusetts, Minnesota, North Carolina, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00000712's enrollment target sits among peer trials
400 80th of 542 higher than 460 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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