NCT00002239

Brief Summary

The purpose of this study is to see if it is safe and effective to give T-20, a new type of anti-HIV drug, with a combination of other anti-HIV drugs. The other anti-HIV drugs used are abacavir (ABC), amprenavir (APV), ritonavir (RTV), and efavirenz (EFV). Three different doses of T-20 are tested.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P25-P50 for phase_2 hiv-infections

Geographic Reach
1 country

20 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

Study Start

First participant enrolled

May 1, 1999

Completed
6 months until next milestone

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

November 15, 2005

Status Verified

November 1, 2005

First QC Date

November 2, 1999

Last Update Submit

November 14, 2005

Conditions

HIV Infections

Keywords

HIV-1Dose-Response Relationship, DrugDrug Therapy, CombinationVX 478Anti-HIV Agentspentafusideabacavirefavirenz

Interventions

EnfuvirtideDRUG
RitonavirDRUG
Abacavir sulfateDRUG
AmprenavirDRUG
EfavirenzDRUG

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 HIV-positive.
  • Have an HIV level (viral load) between 400 and 100,000 copies/ml at the screening visit.
  • Have taken at least 1 PI (protease inhibitor) for at least 16 weeks, and have had no interruptions in their most recent PI-containing anti-HIV drug regimen.
  • Are at least 18 years old.
  • Agree to abstinence or use of 2 effective methods of birth control, including a barrier method, during the study.

You may not qualify if:

  • Patients will not be eligible for this study if they:
  • Have ever taken an NNRTI (nonnucleoside reverse transcriptase inhibitor).
  • Have an opportunistic (HIV-related) infection.
  • Have had an unexplained fever of at least 38.5 C for 7 days in a row within 30 days prior to screening.
  • Have had diarrhea lasting at least 15 days within 30 days prior to screening.
  • Have ever taken abacavir, amprenavir, or efavirenz (ABC, APV, or EFV).
  • Have certain genetic characteristics (drug resistance mutations) that could change the way a drug acts in the body.
  • Are allergic to any of the study medications.
  • Have a tumor other than certain skin or cervical cancers.
  • Are on chemotherapy that cannot be discontinued during the study.
  • Are taking an investigational drug within 30 days prior to screening.
  • Have ever received an HIV vaccine.
  • Are taking certain medications.
  • Abuse drugs or alcohol.
  • Have hemophilia or another blood clotting disorder.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Pacific Oaks Research

Beverly Hills, California, 90211, United States

Location

UCLA Care Ctr

Los Angeles, California, 90095, United States

Location

ViRx Inc

Palm Springs, California, 92262, United States

Location

Donald Northfelt

Palm Springs, California, 92270, United States

Location

UCSD

San Diego, California, 92103, United States

Location

ViRx Inc

San Francisco, California, 94109, United States

Location

Quest Clinical Research

San Francisco, California, 94115, United States

Location

Dupont Circle Physicians Group

Washington D.C., District of Columbia, 200091104, United States

Location

IDC Research Initiative

Altamonte Springs, Florida, 32701, United States

Location

Gary Richmond MD

Fort Lauderdale, Florida, 33316, United States

Location

AIDS Research Consortium of Atlanta

Atlanta, Georgia, 30308, United States

Location

Johns Hopkins Hosp

Baltimore, Maryland, 21287, United States

Location

Washington Univ School of Medicine

St Louis, Missouri, 63110, United States

Location

New York Univ Med Ctr

New York, New York, 10016, United States

Location

Trimeris Inc

Durham, North Carolina, 27707, United States

Location

Associates of Med and Mental Health

Tulsa, Oklahoma, 74114, United States

Location

Pennsylvania Oncology and Hematology Associates

Philadelphia, Pennsylvania, 19106, United States

Location

Philadelphia FIGHT

Philadelphia, Pennsylvania, 19107, United States

Location

Univ of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

Central Texas Clinical Research

Austin, Texas, 78705, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

EnfuvirtideRitonavirabacaviramprenavirefavirenz

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 FactorsThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

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

Study Start

May 1, 1999

Last Updated

November 15, 2005

Record last verified: 2005-11

Locations

US(20)