NCT00002371

Brief Summary

To compare the magnitude and durability of the reduction in plasma HIV RNA in the two treatment groups over the first 12 weeks of treatment. To determine the safety of each of the two treatment groups.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at below P25 for phase_3 hiv-infections

Timeline
Completed

Started Jun 1996

Shorter than P25 for phase_3 hiv-infections

Geographic Reach
3 countries

8 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

June 1, 1996

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 1997

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 1997

Completed
1.9 years 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

May 4, 2011

Status Verified

April 1, 2011

Enrollment Period

1.5 years

First QC Date

November 2, 1999

Last Update Submit

April 28, 2011

Conditions

HIV Infections

Keywords

HIV-1Drug Therapy, CombinationStavudineLamivudineRNA, ViralAnti-HIV AgentsViral Load

Interventions

Indinavir sulfateDRUG
LamivudineDRUG
StavudineDRUG
ZidovudineDRUG

Eligibility Criteria

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

You may qualify if:

  • Patients must have:
  • At least six months of prior cumulative ZDV therapy.
  • Qualifying plasma HIV RNA count of \>= 4 log10 copies/ml obtained within 2 weeks of randomization.

You may not qualify if:

  • Co-existing Condition:
  • Patients with any of the following symptoms or conditions are excluded:
  • Presence of newly diagnosed AIDS defining opportunistic infection requiring acute therapy at time of enrollment.
  • Intractable diarrhea (\>= 6 loose stools/day for \>= 7 consecutive days).
  • Signs and symptoms of bilateral peripheral neuropathy \>= grade 2 at the time of screening.
  • Inability to tolerate oral medication.
  • Any other clinical conditions that in the opinion of the investigator, would make the patient unsuitable for study or unable to comply with the dosing requirements.
  • Concurrent Medication:
  • Excluded:
  • Therapy with agents with systemic myelosuppressive, neurotoxic pancreatotoxic, hepatotoxic or cytotoxic potential.
  • Therapy with rifampin, rifabutin, terfenadine, astemizole, cisapride, triazolam, midazolam and ketoconazole at any time while on indinavir therapy.
  • Patients with any of the following prior conditions or symptoms are excluded:
  • History of acute or chronic pancreatitis.
  • Prior history of bilateral peripheral neuropathy.
  • Intractable diarrhea (\>= 6 loose stools/day for \>= 7 consecutive days) within 30 days prior to study entry.
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Harbor UCLA Med Ctr

Torrance, California, 90502, United States

Location

Univ of South Florida

Tampa, Florida, 33612, United States

Location

SUNY at Stony Brook / Division of Infectious Diseases

Stony Brook, New York, 11794, United States

Location

Houston Clinical Research Network / Div of Montrose Clinic

Houston, Texas, 77006, United States

Location

Univ of Utah / School of Medicine / Div of Infect Dis

Salt Lake City, Utah, 84132, United States

Location

Sunnybrook Health Science Ctr

North York, Ontario, Canada

Location

Montreal Gen Hosp / Div of Clin Immuno and Allergy

Montreal, Quebec, Canada

Location

Univ of Puerto Rico School of Medicine

San Juan, 00927, Puerto Rico

Location

MeSH Terms

Conditions

HIV Infections

Interventions

IndinavirLamivudineStavudineZidovudine

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 CompoundsZalcitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDideoxynucleosidesThymidine

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Start

June 1, 1996

Primary Completion

December 1, 1997

Study Completion

December 1, 1997

Last Updated

May 4, 2011

Record last verified: 2011-04

Locations

PR(1)US(5)CA(2)