NCT Number: NCT00002021
An Open Study of Foscarnet Treatment of Acyclovir-Resistant Herpes Simplex Virus in Patients With the Acquired Immunodeficiency Syndrome and Other Immunodeficiencies
To evaluate the safety and efficacy of intermittent intravenous (IV) foscarnet in the treatment of acyclovir-resistant herpes simplex virus (HSV) infections in AIDS patients and other immunocompromised patients. To evaluate the necessity, efficacy, and safety of IV maintenance foscarnet therapy in preventing recurrent disease. To confirm the pharmacokinetics of intermittent induction and maintenance IV regimens.
Looking for future studies?
Notify MeKey information
Conditions
Age range
12 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
UCLA CARE Ctr, Los Angeles, California, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Concurrent Medication:
Allowed:
- Cyclosporine.
Patients must have AIDS as defined by the CDC or be immunocompromised (transplant patients; other hematologic malignancies with recognized cell-mediated immune deficiency). Patients must also have herpes simplex virus (HSV) infection documented by culture and in vitro resistance to acyclovir by standard laboratory susceptibility or suspected resistance to acyclovir after an acyclovir treatment failure in which acyclovir was administered for at least 2 weeks intravenously at doses of 30 mg/kg/day (or a comparative dose adjusted for renal insufficiency). In vitro susceptibility data must be pending in the latter case. Patients must be able to give informed consent. Patients < 18 years of age may participate with the consent of parent, guardian, or person with power of attorney, or through the provisions of state laws regarding emancipated minors. Patients must have expected survival of at least 6 months.
Prior Medication:
Allowed:
- Cyclosporin.
- Ganciclovir.
Exclusion criteria
Co-existing Condition:
Patients with the following are excluded:
- Known allergy to foscarnet.
- Any clinically significant pulmonary or neurologic impairment (e.g., patients who are intubated or comatose).
Concurrent Medication:
Excluded:
- Any potentially nephrotoxic agent (except cyclosporine).
- Immunomodulators.
- Biologic response modifiers.
- Investigational agents.
Patients with the following are excluded:
- Known allergy to foscarnet.
- Any clinically significant pulmonary or neurologic impairment (e.g., patients who are intubated or comatose).
Prior Medication:
Excluded within 7 days of study entry:
- Any potentially nephrotoxic agent (except cyclosporin).
- Immunomodulators.
- Biologic response modifiers.
- Investigational agents.
Treatment and study plan
Sponsors and collaborators
Lead sponsor
Astra USA
Industry
Registry information
Important dates
- First posted
- Aug 31, 2001
- Registry last updated
- Jun 24, 2005
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Treatment of Acyclovir-Resistant Mucocutaneous Herpes Simplex Disease in Patients With AIDS: Open Label Pilot Study of Topical Trifluridine
NCT00000635
AIDS-Related Opportunistic Infections, Acquired Immunodeficiency Syndrome
San Francisco, California, United States
View Trial DetailsAn Open, Multicenter Study of Foscarnet Treatment of Acyclovir-Resistant Herpes Simplex Virus in Patients With the Acquired Immunodeficiency Syndrome and Other Immunodeficiencies
NCT00002272
AIDS-Related Opportunistic Infections, Acquired Immunodeficiency Syndrome
Houston, Texas, United States
View Trial DetailsComparison of Foscarnet Versus Vidarabine in the Treatment of Herpes Infection in Patients With AIDS Who Have Not Had Success With Acyclovir
NCT00000985
Acquired Immunodeficiency Syndrome, Blood-Borne Infections
Chicago, Illinois, United States
View Trial DetailsThe Effect of Acyclovir Treatment of the Herpes Simplex Virus (HSV) Infection on HIV Levels in the Blood
NCT00001115
Acquired Immunodeficiency Syndrome, Blood-Borne Infections
Palo Alto, California, United States
View Trial Details