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NCT00001038 · ClinicalTrials.gov registry record · Phase 3
A Study of Valacyclovir Hydrochloride in the Prevention of Life-Threatening Cytomegalovirus Disease in HIV-Infected Patients
A Phase 3 study of HIV Infections and Cytomegalovirus Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 3
- Development phase
- 1,200
- Enrollment target
- 20
- Study locations
NCT00001038: Completed Phase 3 study of HIV Infections and Cytomegalovirus Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00001038 is a Phase 3 study of HIV Infections and Cytomegalovirus Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 1,200 participants, above the 444-participant average among 542 other HIV Infections trials with a reported enrollment target (170% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001038, a Phase 3 study of HIV Infections and Cytomegalovirus Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,200 participants
- Enrollment target
- 20
- Study locations
Study Summary
PRIMARY: To evaluate the efficacy of valacyclovir hydrochloride (BW 256U87) in the prevention of cytomegalovirus (CMV) end-organ disease in HIV/CMV co-infected patients with CD4+ lymphocytes \< 100 cells/mm3. To assess the impact of BW 256U87, high-dose oral acyclovir and low-dose oral acyclovir on survival. SECONDARY: To evaluate the effect of BW 256U87 on quality of life, the safety of the drug administered concurrently with standard antiretroviral agents and other essential therapies for the treatment and prevention of opportunistic diseases, and the efficacy of BW 256U87 in suppressing activation of other herpesviruses. To evaluate serologic and virologic risk factors for the development of CMV disease, including assessment of HIV activation, and the risk of developing drug-resistant CMV, HSV, and VZV. Gastrointestinal absorption of acyclovir is not high enough to prevent CMV disease in patients with advanced HIV disease, although there is evidence that high doses of the drug may extend survival. Valacyclovir, a prodrug that is rapidly converted to acyclovir after oral administration, has a higher absorption rate and may therefore provide inhibitory activity against CMV.
Conditions Studied
Interventions
- DRUG Acyclovir
- DRUG Valacyclovir hydrochloride
Study Locations (20)
California
- Los Angeles County - USC Med Ctr - Los Angeles
- CARE Ctr / UCLA Med Ctr - Los Angeles
- Highland Gen Hosp / San Francisco Gen Hosp - Oakland
- Univ of California / San Diego Treatment Ctr - San Diego
- Kaiser Permanente Med Ctr - San Francisco
Massachusetts
- Harvard (Massachusetts Gen Hosp) - Boston
- Boston Med Ctr - Boston
New York
- Mount Sinai Med Ctr - New York
- North Central Bronx Hosp / Bronx Municipal Hosp - The Bronx
Alabama
- Birmingham Veterans Administration Med Ctr - Birmingham
Colorado
- Univ of Colorado Health Sciences Ctr - Denver
Connecticut
- Yale Univ - New Haven
Illinois
- Northwestern Univ Med School - Chicago
Indiana
- Indiana Univ Hosp - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,200 participants |
| Phase | Phase 3 |
What the finished NCT00001038 record still lists
NCT00001038 is an interventional study that assigns participants to a tested intervention. Its 1,200 participants enrollment target places it among the larger protocols in the corpus, above the 444-participant average among 542 other HIV Infections trials with a reported enrollment target (170% higher).
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which Acyclovir is the first listed.
NCT00001038 names 20 study sites across 14 states, led by California, Massachusetts, New York.
Frequently Asked Questions
What is clinical trial NCT00001038 about?
NCT00001038 is a clinical study titled "A Study of Valacyclovir Hydrochloride in the Prevention of Life-Threatening Cytomegalovirus Disease in HIV-Infected Patients". PRIMARY: To evaluate the efficacy of valacyclovir hydrochloride (BW 256U87) in the prevention of cytomegalovirus (CMV) end-organ disease in HIV/CMV co-infected patients with CD4+ lymphocytes \< 100 cells/mm3. To assess the impact of BW 256U87, high-dose oral acyclovir and low-dose oral acyclovir on ...
What is the current status of trial NCT00001038?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,200 participants.
What conditions does trial NCT00001038 study?
This clinical trial studies the following conditions: HIV Infections, Cytomegalovirus Infections.
What interventions are being tested in trial NCT00001038?
The interventions under investigation include: Acyclovir (DRUG), Valacyclovir hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00001038?
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 NCT00001038 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00001038's enrollment target sits among peer trials
1,200 23rd of 542 higher than 520 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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