Completed
Lamivudine Dosage Comparison in Combination Therapy for HIV-1 Infection
What is being tested
Efavirenz
+ Lamivudine
+ Zidovudine
Drug
Who is being recruted
Blood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
Over 18 Years
+17 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Study Start: September 1999
Summary
Principal SponsorGlaxo Wellcome
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 1999
Actual date on which the first participant was enrolled.Patients are randomized to receive the same total dosage of 3TC either twice a day (Group 1) or once a day (Group 2) in combination with ZDV and EFV over 48 weeks. Viral load measurements will be performed at Weeks 4, 8, 12, 16, 20, 24, and every 8 weeks thereafter.
Principal SponsorGlaxo Wellcome
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsHIV Infections
Criteria
5 inclusion criteria required to participate
Agree to practice abstinence or use effective barrier methods of birth control (or, if patient is a woman, unable to have children)
Are 18 years of age or older
Are HIV-positive
Have a CD4 count greater than 100 cells/mm3 within 21 days of study entry
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12 exclusion criteria prevent from participating
Abuse alcohol or drugs to an extent that may make study participation difficult
Are not likely to be able to complete the 48 weeks of study treatment
Are pregnant or breast-feeding
Are taking medications that affect the immune system within 30 days of study entry
Show More Criteria
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 66 locations
Pacific Oaks Research
Beverly Hills, United StatesAIDS Healthcare Foundation
Los Angeles, United StatesTower ID Med Associates
Los Angeles, United StatesCompleted66 Study Centers