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Home > "V" Clinical Trials Conditions > Valganciclovir in Patients with CMV Retinitis and AIDS Who Cannot Take Drugs by Injection  Valganciclovir in Patients with CMV Retinitis and AIDS Who Cannot Take Drugs by Injection
Valganciclovir in Patients with CMV Retinitis and AIDS Who Cannot Take Drugs by Injection
For Condition: HIV Infections,Cytomegalovirus Retinitis
Status: No longer recruiting
Sponsor(s): Hoffmann-La Roche ,
Synopsis: 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.
Details: CMV causes sight- or life-threatening opportunistic infections in people with AIDS. Intravenous agents including ganciclovir, foscarnet, and cidofovir are presently approved as treatments for CMV retinitis within this population. Ganciclovir and foscarnet induction and maintenance therapy require daily infusions and usually require the use of long-term indwelling central venous catheters. Although the treatment interval of cidofovir is longer, administration necessitates the use of pre-hydration and probenecid in order to avoid a risk of renal toxicity. Oral ganciclovir is an alternative to the intravenous formulation for the maintenance treatment of CMV retinitis. However, because blood levels achieved after oral ganciclovir are low compared to intravenous, oral ganciclovir cannot be used for induction therapy. In an attempt to improve the bioavailability of ganciclovir, valganciclovir was developed. Valganciclovir is a ganciclovir prodrug which, when administered orally, is rapidly converted to the active compound ganciclovir during a first-pass process, with the majority of hydrolysis occurring pre-systemically. Studies have shown that valganciclovir tablets allow systemic exposure of ganciclovir comparable to that achieved with recommended doses of intravenous ganciclovir. Patients undergo an ophthalmologic exam by an ophthalmologist and safety and other laboratory tests to establish eligibility. No specific visits are requested by the drug usage plan following enrollment; however, patients should be seen for safety and/or clinical assessments and medication dispensation at periodic visits, consistent with standard of care. An ophthalmologic exam should be performed again at Week 3 (no later than Week 4), at the end of the induction treatment phase consistent with standard of care in order to ensure adequate response to therapy. Valganciclovir is provided on a monthly basis and only as long as the patient is assessed and information provided in a timely manner. This supply will be terminated 1 month subsequent to when the drug is available by prescription, unless otherwise decided.
Eligibility:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment: 500
Location and Contact Information:
IDC Research Initiative
Altamonte Springs, Florida, 32701
United States
Santa Clara Valley Med Ctr
San Jose, California, 95128
United States
North Texas Infectious Disease Consultants
Dallas, Texas, 75246
United States
Quest Clinical Research
San Francisco, California, 94115
United States
Wilbert Jordan
Paramount, California, 90723
United States
Nashville Health Management Foundation / Vanderbilt Univ
Nashville, Tennessee, 37203
United States
Retina - Vitreous Associates Med Group
Beverly Hills, California, 90211
United States
Ingenix Kern McNeill Decatur
Atlanta, Georgia, 30309
United States
Fundacion Gastroenterologia de Diego
San Juan, , 00909
Puerto Rico
Additional Information:
Study ID Numbers: 268C; ML16356
Study Start Date:
Record last reviewed: June 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00017784
Other Cytomegalovirus Retinitis Studies:
1. A Randomized Comparative Pharmacokinetic Study of Oral Ganciclovir After Treatment With Intravenous Ganciclovir for Cytomegalovirus Gastrointestinal Disease in AIDS Patients
2. A Study to Evaluate the Ability of TNFR:Fc to Decrease the Amount of IL-6 (Interleukin-6) and TNF-alpha (Tumor Necrosis Factor) in HIV-Infected Patients
3. A Study of Tecogalan Sodium
4. A Study of Azithromycin in the Prevention of Mycobacterium avium Complex Disease (MAC) in HIV-Infected Patients
5. A Controlled Comparative Trial of Sulfamethoxazole-Trimethoprim Versus Aerosolized Pentamidine for Secondary Prophylaxis of Pneumocystis carinii Pneumonia in AIDS Patients Receiving Azidothymidine (AZT)
Related Studies:
Other Cytomegalovirus Retinitis Clinical Trials
Other California Clinical Trials
Other Beverly Hills Clinical Trials
Valganciclovir in Patients with CMV Retinitis and AIDS Who Cannot Take Drugs by Injection
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