Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
A Study of Valacyclovir Hydrochloride in the Prevention of Life-Threatening Cytomegalovirus Disease in HIV-Infected Patients
NCT00001038 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001038
The ClinicalTrials.gov registry entry for NCT00001038 describes a study currently listed as completed. It is categorized as Phase 3, 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 1,200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. 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: NCT00001038 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Massachusetts, New York. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00001038?
The interventions under investigation include: Acyclovir (DRUG), Valacyclovir hydrochloride (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00001038?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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