A Study of Valacyclovir Hydrochloride in the Prevention of Life-Threatening Cytomegalovirus Disease in HIV-Infected Patients
Public ClinicalTrials.gov record NCT00001038. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind Trial of Valacyclovir Hydrochloride (BW 256U87) Prophylaxis for Opportunistic Cytomegalovirus End-Organ Disease in Patients With Advanced HIV Infection (< 100 CD4+ Lymphocytes)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00001038
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,200 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 13 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Not listed
- Primary completion
- Apr 30, 1996
- Completion
- Not listed
- Last update posted
- Feb 28, 2011
United States locations
- U.S. sites
- 21
- U.S. states
- 15
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Birmingham Veterans Administration Med Ctr | Birmingham | Alabama | 35233 | — |
| Los Angeles County - USC Med Ctr | Los Angeles | California | 90033 | — |
| CARE Ctr / UCLA Med Ctr | Los Angeles | California | 900951793 | — |
| Highland Gen Hosp / San Francisco Gen Hosp | Oakland | California | 946021018 | — |
| Univ of California / San Diego Treatment Ctr | San Diego | California | 921036325 | — |
| Kaiser Permanente Med Ctr | San Francisco | California | 94115 | — |
| Univ of Colorado Health Sciences Ctr | Denver | Colorado | 80262 | — |
| Yale Univ | New Haven | Connecticut | 06519 | — |
| Northwestern Univ Med School | Chicago | Illinois | 60611 | — |
| Indiana Univ Hosp | Indianapolis | Indiana | 462025250 | — |
| Johns Hopkins Hosp | Baltimore | Maryland | 212052196 | — |
| Harvard (Massachusetts Gen Hosp) | Boston | Massachusetts | 02114 | — |
| Boston Med Ctr | Boston | Massachusetts | 02118 | — |
| Washington Univ | St Louis | Missouri | 63110 | — |
| Mount Sinai Med Ctr | New York | New York | 10029 | — |
| North Central Bronx Hosp / Bronx Municipal Hosp | The Bronx | New York | 10467 | — |
| Univ of North Carolina School of Medicine | Chapel Hill | North Carolina | 275997215 | — |
| Ohio State Univ Hosp Clinic | Columbus | Ohio | 432101228 | — |
| Girard Med Ctr | Philadelphia | Pennsylvania | 191046073 | — |
| Univ TX Galveston Med Branch | Galveston | Texas | 775550882 | — |
| Univ of Washington / Madison Clinic | Seattle | Washington | 98122 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 14 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00001038, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 28, 2011 · Synced Sep 3, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00001038 live on ClinicalTrials.gov.