NCT00002108

Brief Summary

To make lamivudine (3TC) available to patients with progressive, symptomatic HIV disease who cannot participate in a controlled clinical trial and who are refractory or unable to tolerate other therapies. To collect data pertaining to the safety of 3TC at two dose levels. To evaluate the effect of 3TC on markers of hepatitis B in co-infected patients at five to ten selected sites.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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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, 1995

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

Drug Therapy, CombinationAcquired Immunodeficiency SyndromeAIDS-Related ComplexAntiviral AgentsZidovudine

Interventions

LamivudineDRUG
ZidovudineDRUG

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Patients must: * Have progressive, symptomatic HIV disease. * Have a mean CD4 count \<= 99 cells/mm3 for adults and \<= 300 cells/mm3 for children (original design was CD4 count \<= 300 cells/mm3 for both adults and children). * Be unable to participate in a controlled trial. * Be refractory to or unable to tolerate other therapies. * Be able to attend clinic on a monthly schedule. * Have consent of parent or guardian if under the age of consent. NOTE: * If a pregnant or breast-feeding woman requests enrollment, her physician should contact Glaxo staff directly to discuss the case. Practice of unsafe sex.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Kern - McNeill International

Morristown, New Jersey, 07960, United States

Location

Related Publications (1)

  • Pluda J, Cooley T, Montaner J, McCaffrey R, Wainberg M, Yarchoan R. Phase I/II study of 3TC (GR109714X) in adults with ARC or AIDS. Int Conf AIDS. 1993 Jun 6-11;9(1):69 (abstract no WS-B26-2)

    BACKGROUND

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

LamivudineZidovudine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

ZalcitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDideoxynucleosidesThymidine

Study Design

Study Type
interventional
Phase
not applicable
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: 1995-11

Locations

US(1)