NCT00040274

Brief Summary

The purpose of this study is to evaluate DPC 817. The safety, dosages, and how the body responds to the drug will be studied.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 hiv-infections

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 25, 2002

Completed
Last Updated

July 19, 2005

Status Verified

July 1, 2005

First QC Date

June 24, 2002

Last Update Submit

July 18, 2005

Conditions

HIV Infections

Keywords

HIVPhase I

Interventions

DPC 817DRUG

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients may be eligible for this study if they:
  • Are HIV positive
  • Are male and are between 18 years of age (or the legal age of consent, whichever is older) and 55 years of age
  • Are female and are between 18 years of age (or the legal age of consent, whichever is older) and 55 years of age and are not able to have children (females may participate in Part B only)
  • Have no clinically significant findings on physical examination or clinical laboratory evaluations
  • Have a CD4-lymphocyte count of 50 or more cells/mm3
  • Are able and willing to comply with the requirements of this study

You may not qualify if:

  • Patients will not be eligible for this study if they:
  • Have an opportunistic infection characteristic of AIDS
  • Are receiving any approved or experimental HIV drugs. Any previous anti-HIV treatment must be stopped at least 4 weeks before the first dose of study medication
  • Are pregnant or breast-feeding
  • Are enrolled in other experimental drug studies or have recieved other experimental drugs within 30 days before the first dose of study drug
  • Have any disease that causes a problem with absorption of drugs
  • Have active hepatitis
  • Have a history of pancreatitis or peripheral neuropathy
  • Have received radiation therapy or chemotherapy within 30 days before the first dose of study drug
  • Have received treatment with drugs that affect the immune system within 30 days before the first dose of study drug or have received an HIV immunotherapeutic vaccine
  • Have taken prescription or over-the-counter products within 14 days of the first dose of study drug unless approved by the doctor
  • Are unable to comply with the dosing schedule and study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of North Carolina Hospitals

Chapel Hill, North Carolina, 27514, United States

Location

3ClincalResearch Center

Berlin, Germany

Location

MeSH Terms

Conditions

HIV Infections

Interventions

dexelvucitabine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 24, 2002

First Posted

June 25, 2002

Last Updated

July 19, 2005

Record last verified: 2005-07

Locations

DE(1)US(1)