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A Study of PMPA in HIV-Infected Patients

Sponsor
Gilead Sciences (Industry)
Overall Status
Completed
CT.gov ID
NCT00002180
Collaborator
(none)
2
Locations

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Masking:
Double
Primary Purpose:
Treatment
Official Title:
A Phase I/II Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerance, and Pharmacokinetics, and Antiviral Activity of 9-[(R)-2-(Phosphonomethoxy)Propyl] Adenine (PMPA) in HIV-Infected Patients

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 0 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 San Francisco Gen Hosp / AIDS Program San Francisco California United States 94110
    2 Johns Hopkins Univ Baltimore Maryland United States 21205

    Sponsors and Collaborators

    • Gilead Sciences

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00002180
    Other Study ID Numbers:
    • 269A
    • GS-96-701
    First Posted:
    Aug 31, 2001
    Last Update Posted:
    Jun 24, 2005
    Last Verified:
    Sep 1, 1999
    Keywords provided by , ,
    Placebos
    Anti-HIV Agents
    Adenine
    Additional relevant MeSH terms:
    HIV Infections
    Tenofovir

    Study Results

    No Results Posted as of Jun 24, 2005