NCT00002419

Brief Summary

The purpose of this study is to see if it is safe and effective to give adefovir dipivoxil plus abacavir (ABC) plus efavirenz (EFV) plus amprenavir (APV) to HIV-infected patients who have failed to respond to previous treatment with protease inhibitors (PIs).

Trial Health

80
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_2 hiv-infections

Geographic Reach
1 country

5 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

November 1, 1999

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

Drug Therapy, CombinationHIV Protease InhibitorsReverse Transcriptase InhibitorsAnti-HIV Agents

Interventions

Abacavir sulfateDRUG
AmprenavirDRUG
EfavirenzDRUG
Adefovir dipivoxilDRUG

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • You may be eligible for this study if you:
  • Are HIV-positive.
  • Had an HIV level of at least 2,000 copies/ml after 6 months of treatment with at least 1 PI other than amprenavir (meaning you failed PI treatment).
  • Are at least 13 years old (need consent of parent or guardian if under 18).
  • Are able to complete the study.
  • Agree to use effective barrier methods of birth control, such as condoms, during the study.

You may not qualify if:

  • You will not be eligible for this study if you:
  • Have certain serious medical conditions, including AIDS-related cancers (except Kaposi's sarcoma) that require treatment during the study.
  • Have ever taken or are allergic to adefovir dipivoxil, ABC, APV, EFV.
  • Are participating in another anti-HIV drug trial during this study.
  • Have taken certain medications within 30 days prior to study entry, including medications that affect your immune system.
  • Have been diagnosed with hepatitis within the past 30 days.
  • Abuse alcohol or drugs.
  • Are pregnant or breast-feeding.
  • Have ever taken NNRTIs.
  • Have ever taken ddI or d4T.
  • Have received chemotherapy or radiation therapy within 30 days prior to study entry.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Pacific Oaks Med Group

Beverly Hills, California, 90211, United States

Location

Univ of Colorado / Health Science Ctr

Denver, Colorado, 80262, United States

Location

AIDS Research Consortium of Atlanta

Atlanta, Georgia, 30308, United States

Location

Brown Univ School of Medicine

Providence, Rhode Island, 02908, United States

Location

Hampton Roads Med Specialists

Hampton, Virginia, 23666, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

abacaviramprenavirefavirenzadefovir dipivoxil

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 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: 1999-11

Locations

US(5)