NCT00002228

Brief Summary

The purpose of this study is to see if it is safe and effective to give T-20 to HIV-positive adults. T-20 is an anti-HIV drug.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P25-P50 for phase_2 hiv-infections

Geographic Reach
1 country

11 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

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

April 1, 1999

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

Injections, SubcutaneousHIV-1Anti-HIV Agentspeptide T20

Interventions

EnfuvirtideDRUG

Eligibility Criteria

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

You may qualify if:

  • Concurrent Medication:
  • Allowed:
  • Any antiretroviral agent, provided the regimen has not changed within 6 weeks of the screening visit.
  • Antibiotics for bacterial infections.
  • Prophylactic medications for P. carinii pneumonia and for M. avium, including azithromycin.
  • Medications for symptomatic treatment such as antipyretics, analgesics, and antiemetics.
  • Patients must have:
  • HIV-1 seropositive status.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Concurrent neoplasm (except for basal cell carcinoma of the skin, in situ carcinoma of the cervix, and non-disseminated stable Kaposi's sarcoma).
  • Concurrent Medication:
  • Excluded:
  • Patients must not be taking any concurrent antiretroviral therapy (for at least 2 weeks prior to baseline) or the patient is to be on a stable antiretroviral regimen which has not changed for at least 6 weeks prior to baseline.
  • Treatment with any of the following:
  • immunomodulators, biological response modifiers, chemotherapy that cannot be discontinued for the duration of the study, astemizole, terfenadine, cisapride, triazolam, midazolam, rifampin, clarithromycin, or an investigational drug within 30 days prior to the initial visit.
  • Patients with the following prior conditions are excluded:
  • Evidence of active opportunistic infections, or unexplained temperature greater than or equal to 38.5 Celsius for 7 consecutive days within 30 days prior to screening visit.
  • Chronic diarrhea (defined as greater than 3 liquid stools per day which persists for 15 days) within 30 days prior to screening visit.
  • Diagnosis of hemophilia or other clotting disorders.
  • Prior Medication:
  • Excluded:
  • \- Prior treatment with an HIV vaccine.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Univ of Alabama at Birmingham / 1917 AIDS O/P Cln

Birmingham, Alabama, 35294, United States

Location

UCLA School of Medicine / Ctr for Research and Education

Los Angeles, California, 900951793, United States

Location

San Francisco Gen Hosp

San Francisco, California, 94110, United States

Location

Quest Clinical Research

San Francisco, California, 94115, United States

Location

IDC Research Initiative

Altamonte Springs, Florida, 32701, United States

Location

Northwestern Univ / Infect Dis Div / Pasavant Pav 828

Chicago, Illinois, 60611, United States

Location

Johns Hopkins Hosp

Baltimore, Maryland, 21287, United States

Location

CRI of New England

Brookline, Massachusetts, 02445, United States

Location

NYU Med Ctr / C & D Building

New York, New York, 10016, United States

Location

Univ North Carolina at Chapel Hill / Dept of Medicine

Chapel Hill, North Carolina, 27599, United States

Location

Univ of Texas / Thomas Street Clinic

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Enfuvirtide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Peptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsHIV Envelope Protein gp41Viral Fusion ProteinsMembrane Fusion ProteinsMembrane ProteinsProteinsHIV AntigensAntigens, ViralViral Proteinsenv Gene Products, Human Immunodeficiency VirusGene Products, envRetroviridae ProteinsHuman Immunodeficiency Virus ProteinsViral Envelope ProteinsViral Structural ProteinsAntigensBiological Factors

Study Officials

  • Sam Hopkins

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1999-04

Locations

US(11)