Completed

PMPA Safety, Tolerance, and Antiviral Activity in HIV-Infected Patients

What is being tested

Tenofovir

Drug

Who is being recruted

Blood-Borne Infections+11

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years

+13 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

See protocol details

Summary

Principal SponsorGilead Sciences

Last updated: June 24, 2005

Sourced from a government-validated database.Claim as a partner

This study focuses on HIV-infected individuals and investigates a drug called PMPA. The main goal is to understand if PMPA is safe and effective for treating HIV. The study also aims to learn how the body processes this drug, which could help improve future treatments for HIV. During this study, participants receive PMPA. The study is designed to monitor the safety of the drug and observe how well it works against HIV. It also measures how quickly the body breaks down and eliminates PMPA. This information helps researchers understand the potential benefits and risks of using PMPA for treating HIV.

NCT00002180

Principal SponsorGilead Sciences

Last updated: June 24, 2005

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsHIV Infections

Criteria

4 inclusion criteria required to participate

Laboratory diagnosis of HIV infection.

Plasma HIV RNA >= 10,000 copies/ml within 28 days of entry.

CD4 cell count >= 200 cells/mm3 within 28 days prior to entry.

Minimum life expectancy of 12 months.

9 exclusion criteria prevent from participating

Positive test for Hepatitis B surface antigen or Hepatitis C antibody in serum.

History of malignancy other than basal cell carcinoma or cutaneous Kaposi's sarcoma.

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.

Show More Criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

San Francisco Gen Hosp / AIDS Program

San Francisco, United StatesOpen San Francisco Gen Hosp / AIDS Program in Google Maps

Johns Hopkins Univ

Baltimore, United States

Completed2 Study Centers