A Study of PMPA in HIV-Infected Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00002180
• Date of registration: 02/11/1999
• Primary sponsor: Gilead Sciences
• Public title: A Study of PMPA in HIV-Infected Patients
• Scientific 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
• Date of first enrolment: May 1997
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00002180
• Study type: Interventional
• Study design: Endpoint Classification: Pharmacokinetics Study, Masking: Double-Blind, Primary Purpose: Treatment

Countries of recruitment

United States

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infections

Intervention(s)

Drug: Tenofovir

Secondary ID(s)

269A

GS-96-701

Source(s) of Monetary Support

Please refer to primary and secondary sponsors