HIV Infections Clinical Trial
Official title:
Open-Label Safety Study of Valganciclovir in Patients With CMV Retinitis and AIDS Who Have Complications Due to IV Treatment
NCT number | NCT00017784 |
Other study ID # | 268C |
Secondary ID | ML16356 |
Status | Active, not recruiting |
Phase | Phase 3 |
First received | June 11, 2001 |
Last updated | June 23, 2005 |
The purpose of this study is to make valganciclovir available, before it is approved for
marketing, to HIV-infected patients who have cytomegalovirus (CMV) retinitis (eye infection)
and cannot take drugs by injection. This study also will look at the safety of using
valganciclovir as starting and/or ongoing therapy.
CMV can cause serious AIDS-related infections in patients with HIV. Drugs that are effective
against CMV eye infections can be given only by injection; this calls for a thin tube to be
placed into a vein in the chest so that the patient is not put through getting too many
needle sticks. An experimental drug, valganciclovir, is similar to 1 of these approved
drugs, ganciclovir, but is more convenient and easier to use since it can be taken by mouth.
Once in the body, valganciclovir changes to ganciclovir. Studies have shown that
valganciclovir tablets can result in the same level of ganciclovir in the blood as
ganciclovir injection.
Status | Active, not recruiting |
Enrollment | 500 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria Patients may be eligible for this study if they: - Are 18 years of age or older. - Are HIV-positive. - Have active CMV retinitis, shown by an eye exam by an eye doctor, that needs treatment. - Have had problems when drugs were given by injection, such as difficulty in finding a vein or problems (blood clots, vein inflammation, or infection) caused by injection devices. - Agree to use effective methods of birth control (i.e., barrier methods) during the study and for 90 days after taking the study drug. Females who can have children must have a negative pregnancy test before entering the study. - Stop breast-feeding before starting the study drug. Exclusion Criteria Patients will not be eligible for this study if they: - Are pregnant or breast-feeding. - Have developed CMV retinitis after a transplant. - Have kidney disease and need hemodialysis. - Are taking part in another drug study, unless approved by the study doctor. - Take experimental drugs, or have taken them within 30 days before study entry, unless approved by the study doctor. - Take drugs not allowed on the study, including foscarnet, cidofovir, and probenecid. - Are not able to follow study procedures, including visits to the eye doctor and the study doctor. |
Endpoint Classification: Safety Study, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Puerto Rico | Fundacion Gastroenterologia de Diego | San Juan | |
United States | IDC Research Initiative | Altamonte Springs | Florida |
United States | Ingenix Kern McNeill Decatur | Atlanta | Georgia |
United States | Retina - Vitreous Associates Med Group | Beverly Hills | California |
United States | North Texas Infectious Disease Consultants | Dallas | Texas |
United States | Nashville Health Management Foundation / Vanderbilt Univ | Nashville | Tennessee |
United States | Wilbert Jordan | Paramount | California |
United States | Quest Clinical Research | San Francisco | California |
United States | Santa Clara Valley Med Ctr | San Jose | California |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
United States, Puerto Rico,
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