Completed
Efavirenz, Stavudine, and Lamivudine Combination for HIV Treatment in Antiretroviral Therapy-Naive Patients
What is being tested
Efavirenz
+ Lamivudine
+ Stavudine
Drug
Who is being recruted
Blood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
Over 13 Years
+19 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Summary
Principal SponsorDupont Merck
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Patients will be given combination treatment with efavirenz, stavudine, and lamivudine.
Principal SponsorDupont Merck
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.Design Details
60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.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 13 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
2 inclusion criteria required to participate
Documented diagnosis of HIV infection with plasma HIV-RNA greater than or equal to 10,000 copies/ml
Life expectancy of at least 12 months
17 exclusion criteria prevent from participating
Any active AIDS-defining opportunistic infection or disease
Any clinically significant disease (other than HIV infection) or clinically significant findings found during the screening of medical history or physical examination
Any clinically significant laboratory findings obtained during the screening evaluation (see laboratory values)
Any malignancy that requires systemic therapy
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 8 locations
The Whitman Walker Clinic
Washington D.C., United StatesCommunity Research Initiative of New England
Brookline, United StatesRemington Davis Inc
Columbus, United StatesCompleted8 Study Centers