Clinical trial NCT00002346: The Safety and Effectiveness of Bis-POM PMEA in HIV-Infected Patients
Official title: A Phase I/II Study of Safety, Tolerance, Pharmacokinetics, and Anti-HIV Activity of 9-[2-(Bispivaloyloxymethyl)Phosphonylmethoxyethyl]Adenine (Bis-POM PMEA) and Placebo in HIV-Infected Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Antiviral Agents
Adenine
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Univ
state: Maryland
Study officials:
References:
citation: James JS. GS 840 (adefovir dipivoxil): broad-spectrum antiviral trial, CD4 count under 100. AIDS Treat News. 1997 Feb 7;(No 264):4-5.