NCT00002386

Brief Summary

The purpose of this study is to see if indinavir plus two other anti-HIV drugs affect blood clotting in HIV-positive patients with hemophilia.

Trial Health

85
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for phase_4 hiv-infections

Geographic Reach
2 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

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

June 1, 1999

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

Keywords

Drug Therapy, CombinationHIV Protease InhibitorsIndinavirFactor VIIIFactor IXHalf-LifeReverse Transcriptase InhibitorsAnti-HIV AgentsPlatelet AggregationHemophilia AHemophilia B

Interventions

Eligibility Criteria

Age16 Years+
Sexmale
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 an HIV-positive male.
  • Have been diagnosed with hemophilia.
  • Have been taking clotting factors for hemophilia for at least 6 months.
  • Have been taking a combination of one protease inhibitor plus two other anti-HIV drugs for at least 6 months, or have never taken a protease inhibitor.
  • Are at least 16 years old (consent of parent or guardian required if under 18).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

USCF

San Francisco, California, 94143, United States

Location

Georgetown U Med Ctr / Div of Hematology / Oncology

Washington D.C., District of Columbia, 20007, United States

Location

Emory Univ

Atlanta, Georgia, 30322, United States

Location

Riley Hosp for Children

Indianapolis, Indiana, 462025225, United States

Location

Tulane Univ School of Medicine / Hematology / Oncology

New Orleans, Louisiana, 70112, United States

Location

Univ of North Carolina School of Medicine / Div Hemat / Onco

Chapel Hill, North Carolina, 275997035, United States

Location

Milton Hershey Med Ctr

Hershey, Pennsylvania, 170330850, United States

Location

Montreal Gen Hosp

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

HIV InfectionsHemophilia AHemophilia B

Interventions

IndinavirLamivudineStavudineZidovudineZalcitabineDidanosine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesBlood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, X-Linked

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDideoxynucleosidesThymidineInosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingRibonucleosides

Study Design

Study Type
interventional
Phase
phase 4
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: 1999-06

Locations