The Safety and Effectiveness of Bis-POM PMEA in HIV-Infected Patients

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

36 participants

Study Classification

INTERVENTIONAL

Brief Summary

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To study the safety, tolerance, single and multiple dose pharmacokinetics, and anti-HIV activity of bis-POM PMEA ( adefovir dipivoxil ) versus placebo when administered orally on a daily basis for 2 weeks to HIV-infected patients.

Detailed Description

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Patients are randomized to receive bis-POM PMEA at one of three fixed dose levels or placebo daily for 2 weeks. At each dose level, nine patients receive bis-POM PMEA and three patients receive placebo.

Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Adefovir dipivoxil

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Concurrent Medication:

Allowed:

* Prophylaxis with aerosolized pentamidine, fluconazole, ketoconazole, trimethoprim/sulfamethoxazole, or dapsone, provided a stable regimen has been maintained for at least 4 weeks prior to study entry.

Patients must have:

* HIV seropositivity.
* CD4 count \>= 100 cells/mm3.
* p24 antigen (immune-complex dissociated) \>= 50 pg/ml.
* Life expectancy of at least 6 months.

Prior Medication:

Allowed:

* Prior prophylaxis with aerosolized pentamidine, fluconazole, ketoconazole, trimethoprim/sulfamethoxazole, or dapsone.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Active, serious infection (other than HIV infection) requiring parenteral antibiotic therapy.
* Malignancy other than cutaneous Kaposi's sarcoma.
* Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia.
* Gastrointestinal malabsorption syndrome.
* Inability to take oral medication.

Concurrent Medication:

Excluded:

* Any parenteral antibiotic therapy.
* Diuretics.
* Amphotericin B.
* Didanosine (ddI).
* Fluconazole.
* Foscarnet.
* Ganciclovir.
* Interferon-alpha.
* Interferon-beta.
* Isoniazid.
* Aminoglycoside antibiotics.
* Ketoconazole (topical allowed).
* Itraconazole.
* Rifabutin.
* Rifampin.
* Stavudine (d4T).
* Zalcitabine (ddC).
* Zidovudine (AZT).
* Lamivudine (3TC).
* Any investigational agents (except with sponsor approval).
* Systemic therapy for Kaposi's sarcoma.

Patients with the following prior condition are excluded:

History of lactose intolerance.

Prior Medication:

Excluded within 2 weeks prior to study entry:

* Any parenteral antibiotic therapy.
* Diuretics.
* Amphotericin B.
* Didanosine (ddI).
* Fluconazole.
* Foscarnet.
* Ganciclovir.
* Interferon-alpha.
* Interferon-beta.
* Isoniazid.
* Aminoglycoside antibiotics.
* Ketoconazole (topical allowed).
* Itraconazole.
* Rifabutin.
* Rifampin.
* Stavudine (d4T).
* Zalcitabine (ddC).
* Zidovudine (AZT).
* Lamivudine (3TC).
* Any investigational agents (except with sponsor approval).

Excluded within 4 weeks prior to study entry:

Systemic therapy for Kaposi's sarcoma. Active substance abuse (including alcohol) as determined by questionnaire or positive drug screen.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Johns Hopkins Univ

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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James JS. GS 840 (adefovir dipivoxil): broad-spectrum antiviral trial, CD4 count under 100. AIDS Treat News. 1997 Feb 7;(No 264):4-5.

Reference Type BACKGROUND

PMID: 11364103 (View on PubMed)

Other Identifiers

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GS-93-402

Identifier Type: -

Identifier Source: secondary_id

232B