Completed

Topical HPMPC for Condyloma Acuminatum in HIV Patients

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Cidofovir

Drug
Who is being recruted

Blood-Borne Infections+28

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+24 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

Four groups of 10 patients each receive topical HPMPC at 0.3 percent concentration for 5 or 10 days total or 1.0 percent concentration for 5 or 10 days total, followed by 2 weeks of rest. When six patients at a given dose and schedule have completed treatment and follow-up without significant toxicity, subsequent patients are entered at the next higher dose level. Patients are evaluated twice weekly during treatment and once weekly during the rest period. HPMPC may be extended for up to two additional courses in patients who experience no significant toxicity.

NCT00002327
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.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

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 DiseasesDNA Virus InfectionsImmunologic Deficiency SyndromesImmune System DiseasesInfectionsOpportunistic InfectionsPathologic ProcessesRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSkin DiseasesSkin Diseases, InfectiousSlow Virus DiseasesPathological Conditions, Signs and SymptomsTumor Virus InfectionsVirus DiseasesWartsSexually Transmitted Diseases, ViralLentivirus InfectionsSkin Diseases, ViralSkin and Connective Tissue DiseasesDisease AttributesPapillomavirus InfectionsAcquired Immunodeficiency SyndromeAIDS-Related ComplexCondylomata AcuminataHIV InfectionsAIDS-Related Opportunistic Infections

Criteria

10 inclusion criteria required to participate
Rifabutin.

AZT, ddI, ddC, d4T, or 3TC.

Aerosolized pentamidine.

Dapsone.

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14 exclusion criteria prevent from participating
Liquid nitrogen treatment.

Other treatments, topical or systemic, surgical or ablative, known to have anti-papilloma activity.

Other investigative drugs (except d4T or 3TC) unless approved by the sponsor.

Podofilox or any podophyllum resin preparation.

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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 11 locations

East Bay AIDS Ctr

Berkeley, United StatesOpen East Bay AIDS Ctr in Google Maps

Univ California San Francisco

San Francisco, United States

City and County of Denver / Dept of Health & Hosps

Denver, United States

Univ of Rochester Med Ctr

Rochester, United States
Completed11 Study Centers