A Phase I/II Study of the Safety, Tolerance, and Pharmacokinetics of 9-(2-Phosphonylmethoxyethyl)Adenine ( PMEA; Adefovir ) in Patients With Advanced HIV Disease.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Brief Summary

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To study the safety, tolerance, pharmacokinetics, and anti-HIV effects of PMEA ( adefovir ) when administered daily by intravenous (IV) and/or subcutaneous (SC) injection in patients with advanced HIV disease.

Detailed Description

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Patients receive a single IV or SC dose of PMEA daily for 4 weeks. A maximum tolerated dose will be defined for these regimens.

Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Adefovir

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Concurrent Medication:

Allowed:

* Other antiretroviral therapy IF on a stable dose for at least 4 weeks prior to study entry.
* Prophylactic therapy with aerosolized pentamidine, oral trimethoprim/sulfamethoxazole (Bactrim, Septra) or dapsone, and fluconazole or ketoconazole IF on a stable prophylactic regimen for at least 4 weeks prior to study entry.

Patients must have:

* HIV seropositivity.
* Elevated p24 antigen (\> 40 pg/ml).
* Mean CD4 count \<= 100 cells/mm3.
* Life expectancy of at least 3 months.

Prior Medication:

Allowed:

* Other prior antiretroviral therapy.
* Prophylactic therapy with aerosolized pentamidine, oral trimethoprim/sulfamethoxazole (Bactrim, Septra) or dapsone, and fluconazole or ketoconazole.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Inadequate venous access.
* Active serious infection (other than HIV infection) requiring parenteral antibiotic therapy.
* Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia.
* Psychiatric disturbance or illness that may affect compliance.
* Malignancy other than Kaposi's sarcoma.

Concurrent Medication:

Excluded:

* Investigational agents other than stavudine (d4T).
* Interferon-alpha.
* Ganciclovir.
* Foscarnet.
* Diuretics.
* Amphotericin B.
* Aminoglycoside antibiotics.
* Other nephrotoxic agents.
* Acyclovir at doses \>= 2 g/day.

Prior Medication:

Excluded within 2 weeks prior to study entry:

* Investigational agents other than stavudine (d4T).
* Interferon-alpha.
* Ganciclovir.
* Foscarnet.
* Diuretics.
* Amphotericin B.
* Aminoglycoside antibiotics.
* Other nephrotoxic agents.

Excluded within 4 weeks prior to study entry:

* Systemic therapy for Kaposi's sarcoma. Substance abuse.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Univ of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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GS-92-202

Identifier Type: -

Identifier Source: secondary_id

217A