NCT00006209

Brief Summary

The purpose of this study is to see if it is safe to give tucaresol to HIV-infected patients who are taking combination anti-HIV therapy (HAART). This study also examines the effect tucaresol has on viral load (level of HIV in the body) when tucaresol is used with HAART.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 hiv-infections

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

June 1, 2000

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2000

Completed
12 months until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

June 1, 2001

First QC Date

September 11, 2000

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

HIV-1Immunity, CellularDrug Therapy, CombinationCD4-Positive T-LymphocytesAntigensAnti-HIV AgentsViral Loadtucaresol

Interventions

TucaresolDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients may be eligible for this study if they:
  • Are at least 18 years old.
  • Are HIV-positive.
  • Have more than 300 CD4 T cells/microL at screening.
  • Are taking certain anti-HIV drugs.
  • Have been taking these anti-HIV drugs successfully for at least 6 months.
  • Do not expect to change their anti-HIV therapy while they are in the study.
  • Have had plasma viral load less than 50 copies/ml while on their anti-HIV therapy.
  • Have viral load that cannot be detected at screening and baseline tests.
  • Are able to complete weekly visits.

You may not qualify if:

  • Patients will not be eligible for this study if they:
  • Cannot give informed consent.
  • Have abnormal laboratory test results at baseline.
  • Are pregnant or breast-feeding.
  • Have had certain short-term or long-term illnesses (such as heart disease, sickle cell disease, anemia, or lung problems).
  • Have received a vaccination within the 30 days prior to enrollment.
  • Have received any other experimental drug within 60 days of enrollment.
  • Are taking abacavir (Ziagen, GW1592) or drugs that affect the immune system, such as IL-2, GM-CSF, corticosteroids, or cyclosporine.
  • Have a history of tumors.
  • Are actively using illegal drugs (methadone is allowed).
  • Have hepatitis B or hepatitis C.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rockefeller Univ

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

tucaresol

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
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 11, 2000

First Posted

August 31, 2001

Study Start

June 1, 2000

Last Updated

June 24, 2005

Record last verified: 2001-06

Locations

US(1)