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Home > "A" Clinical Trials Conditions > A Study of PMPA in HIV-Infected Patients  A Study of PMPA in HIV-Infected Patients
A Study of PMPA in HIV-Infected Patients
For Condition: HIV Infections
Status: Completed
Sponsor(s): Gilead Sciences ,
Synopsis: The purpose of this study is to see if it is safe and effective to give PMPA to HIV-infected patients. This study also examines how the body handles PMPA.
Details:
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - Laboratory diagnosis of HIV infection. - CD4 cell count >= 200 cells/mm3 within 28 days prior to entry. - Plasma HIV RNA >= 10,000 copies/ml within 28 days of entry. - Minimum life expectancy of 12 months. Exclusion Criteria Co-existing Condition: Patients with any of the following symptoms or conditions are excluded: - Active, serious infections (other than HIV) that require parental antibiotic therapy. Patients may be considered recovered if at least 2 weeks have elapsed following cessation of parental therapy before enrollment. - Active clinically significant medical problems that include cardiac disease (e.g., symptoms of ischemia, congestive heart failure, or arrhythmia). - Positive test for Hepatitis B surface antigen or Hepatitis C antibody in serum. Patients with any of the following prior conditions are excluded: History of malignancy other than basal cell carcinoma or cutaneous Kaposi's sarcoma. Patients who are receiving: - Antiretroviral therapy, including nucleoside analogs, non-nucleoside reverse transcriptase inhibitors, protease inhibitors or investigational antiretroviral agents. - Interferon or interleukin therapy, aminoglycoside antibiotics, amphotericin B, cidofovir, diuretics, foscarnet, ganciclovir, itraconazole, fluconazole, ketoconazole (topical allowed), isoniazid, rifampin, rifabutin, clarithromycin, azithromycin, systemic chemotherapeutic agents, systemic corticosteroids, other agents with significant nephrotoxic potential, other agents that may inhibit or compete for elimination via active renal tubular secretion (probenecid) and other investigational agents. Within 2 weeks prior to entry: - Antiretroviral therapy, including nucleoside analogs, non-nucleoside reverse transcriptase inhibitors, protease inhibitors or investigational antiretroviral agents. - Interferon or interleukin therapy, aminoglycoside antibiotics, amphotericin B, cidofovir, diuretics, foscarnet, ganciclovir, itraconazole, fluconazole, ketoconazole (topical allowed), isoniazid, rifampin, rifabutin, clarithromycin, azithromycin, systemic chemotherapeutic agents, systemic corticosteroids, other agents with significant nephrotoxic potential, other agents that may inhibit or compete for elimination via active renal tubular secretion (probenecid) and other investigational agents. Active drug or alcohol abuse as demonstrated by a positive screening test for drugs of abuse (except marijuana or drugs used for medical indications), or substance abuse considered sufficient to hinder patient compliance.
Total Enrollment:
Location and Contact Information:
Johns Hopkins Univ
Baltimore, Maryland, 21205
United States
San Francisco Gen Hosp / AIDS Program
San Francisco, California, 94110
United States
Additional Information:
Study ID Numbers: 269A; GS-96-701
Study Start Date:
Record last reviewed: September 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002180
Other Hiv Infections Studies:
1. Immune Responses in HIV-Positive Patients Receiving an Anti-HIV Drug Combination When Given the HIV Vaccines Remune and vCP1452
2. A Randomized Phase III Clinical Trial of Daunoxome Versus Combination Chemotherapy With Adriamycin/Bleomycin/Vincristine (ABV) in the Treatment of HIV-Associated Kaposi's Sarcoma.
3. Identifying Emergency Room Patients Who Have Recently Been Infected with HIV
4. A Study of Stavudine in HIV-Infected Patients Who Have Not Had Success with Other Anti-HIV Drugs
5. Studies of Ocular Complications of AIDS (SOCA)--Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT)
Related Studies:
Other HIV Infections Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
A Study of PMPA in HIV-Infected Patients
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