NCT00002235

Brief Summary

Indinavir is usually taken three times a day. The purpose of this study is to see if it is safe and effective to take indinavir only twice a day plus nelfinavir (also taken twice a day) and efavirenz (taken once a day).

Trial Health

80
On Track

Trial Health Score

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

Enrollment
6

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

March 1, 2000

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

Drug Therapy, CombinationHIV Protease InhibitorsIndinavirNelfinavirReverse Transcriptase InhibitorsAnti-HIV Agentsefavirenz

Interventions

Indinavir sulfateDRUG
Nelfinavir mesylateDRUG
EfavirenzDRUG

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.
  • Are at least 13 years old (consent of parent or guardian required if under 18).
  • Have a viral load of at least 10,000 copies/ml within 30 days of study entry.
  • Agree to use a barrier method 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 hepatitis.
  • Have any other serious medical condition besides HIV infection.
  • Are allergic to indinavir, nelfinavir, or efavirenz.
  • Have ever taken NNRTIs or protease inhibitors.
  • Have had chemotherapy or radiation therapy within 30 days of study entry. (Local radiation therapy is allowed.)
  • Have taken certain other medications that might affect your immune system such as interleukin-2, interferon, or a vaccine within 30 days of study entry.
  • Are enrolled or plan to enroll in another anti-HIV drug study during this study.
  • Are pregnant or breast-feeding.
  • Abuse alcohol or drugs.

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

IndinavirNelfinavirefavirenz

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)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
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: 2000-03

Locations

US(5)