A Study of Valacyclovir Hydrochloride in the Prevention of Life-Threatening Cytomegalovirus Disease in HIV-Infected Patients
Completed · Phase 3
Conditions studied: Cytomegalovirus Infections, HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00001038
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 1200
- Last updated by the study team
- 2011-03-01
Who can join
Age: 13 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Concurrent Medication:
- Recommended:
- PCP prophylaxis.
- Allowed:
- Any antiretroviral therapies available by prescription or through expanded access or Treatment IND programs, including combination or sequential use.
- Chemotherapy for Kaposi's sarcoma, lymphoma, or other malignancies IF patient is hematologically stable for at least 30 days prior to study entry.
- Discrete courses of oral or parenteral acyclovir for VZV or HSV infection, not to exceed 21 days per episode (may co-enroll on ACTG 169). For recurrent episodes, open-label acyclovir for a total of 60 days over a 12-month period is allowed. Study drug is interrupted.
- Supportive therapies available by prescription, expanded access, or Treatment IND programs, such as G-CSF, GM-CSF, and erythropoietin.
- Other medications necessary for the patient's welfare, at the discretion of the investigator.
- Patients must have:
- HIV infection or AIDS-defining conditions.
- CD4+ count < 100 cells/mm3.
- IgG antibodies to CMV.
- No active CMV disease or history of CMV end-organ disease.
- Consent of parent or guardian if less than 18 years of age.
- Ability to comply with protocol.
- NOTE:
- Patients may be co-enrolled in ACTG primary infection Phase II/III studies, ACTG opportunistic infection protocols, or treatment protocols or similar studies sponsored by other research networks as long as those studies do not violate the restrictions placed on concomitant therapies and toxicity management.
- Prior Medication:
- Allowed:
- PCP prophylaxis.
- Any antiretroviral therapies available by prescription or through expanded access or Treatment IND programs, including combination or sequential use.
- Chemotherapy for Kaposi's sarcoma, lymphoma, or other malignancies.
- Acyclovir.
- Supportive therapies available by prescription, expanded access, or Treatment IND programs, such as G-CSF, GM-CSF, and erythropoietin.
You may not qualify if…
- Co-existing Condition:
- Patients with the following symptoms and conditions are excluded:
- Nausea or vomiting that precludes oral dosing.
- Ocular media opacities that preclude adequate visualization of fundi.
- Pregnancy.
- Known hypersensitivity to acyclovir.
- Known lactose intolerance.
- Concurrent Medication:
- Excluded:
- Systemic interferons and immunomodulators (including CMV hyperimmune serum/globulin and chronic corticosteroids at doses in excess of physiologic replacement).
- Probenecid.
- Investigational or marketed agents with potential activity against CMV, herpes simplex, and/or Varicella zoster, EXCEPT as specifically allowed.
- Patients with the following prior condition are excluded:
- Pre-existing necrotizing retinopathy that may interfere with a subsequent diagnosis of CMV retinitis.
- Prior Medication:
- Excluded:
- Prior ganciclovir, foscarnet, or any investigational anti-CMV agent including use of foscarnet for acyclovir-resistant herpes.
- Interferons, immunomodulators (other than colony stimulating factors), or CMV hyperimmune globulin within 30 days prior to study entry.
Where it is running
- Birmingham Veterans Administration Med Ctr — Birmingham, Alabama, United States
- Los Angeles County - USC Med Ctr — Los Angeles, California, United States
- CARE Ctr / UCLA Med Ctr — Los Angeles, California, United States
- Highland Gen Hosp / San Francisco Gen Hosp — Oakland, California, United States
- Univ of California / San Diego Treatment Ctr — San Diego, California, United States
- Kaiser Permanente Med Ctr — San Francisco, California, United States
- Univ of Colorado Health Sciences Ctr — Denver, Colorado, United States
- Yale Univ — New Haven, Connecticut, United States
- Northwestern Univ Med School — Chicago, Illinois, United States
- Indiana Univ Hosp — Indianapolis, Indiana, United States
- Johns Hopkins Hosp — Baltimore, Maryland, United States
- Harvard (Massachusetts Gen Hosp) — Boston, Massachusetts, United States
- Boston Med Ctr — Boston, Massachusetts, United States
- Washington Univ — St Louis, Missouri, United States
- Mount Sinai Med Ctr — New York, New York, United States
- North Central Bronx Hosp / Bronx Municipal Hosp — The Bronx, New York, United States
- Univ of North Carolina School of Medicine — Chapel Hill, North Carolina, United States
- Ohio State Univ Hosp Clinic — Columbus, Ohio, United States
- Girard Med Ctr — Philadelphia, Pennsylvania, United States
- Univ TX Galveston Med Branch — Galveston, Texas, United States
- Univ of Washington / Madison Clinic — Seattle, Washington, United States
- Saint Vincent's Hosp Med Centre — Sydney, Australia
- Southern Alberta HIV Clinic / Foothills Hosp — Calgary, Alberta, Canada
- Sunnybrook Health Science Ctr — Toronto, Ontario, Canada
- Toronto Hosp — Toronto, Ontario, Canada
Full record on ClinicalTrials.gov
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