Completed
Combivir with 1592U89 or Indinavir for HIV-1 Treatment in Antiretroviral Therapy-Naive Subjects
What is being tested
Indinavir sulfate
+ Lamivudine/Zidovudine
+ Abacavir sulfate
Drug
Who is being recruted
Blood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
Over 16 Years
+14 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 3
Interventional
Summary
Principal SponsorGlaxo Wellcome
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
In this international study, 550 patients are randomized (225 per arm) to receive Combivir in combination with 1592U89 or indinavir. If after 16 weeks (and every 8 weeks thereafter until week 48) a patient has HIV-1 RNA >= 400 copies/ml (by PCR on two occasions >= 1 week and < 4 weeks apart), the patient has the option to switch to open-label therapy consisting of indinavir, 1592U89, and Combivir.
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.Design Details
550 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 16 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
CD4+ cell count >= 100 cells/mm3 within 14 days prior to study drug administration
HIV-1 RNA >= 10,000 copies/ml within 14 days prior to study drug administration
HIV-1 infection documented by a licensed HIV-1 antibody ELISA and confirmed by Western blot detection of HIV-1 antibody or positive HIV-1 blood culture
No active diagnosis of AIDS according to the 1993 Centers for Disease Control (CDC) AIDS surveillance definition (excluding CD4+ cell counts < 200 cells/mm3)
Show More Criteria
9 exclusion criteria prevent from participating
Current alcohol or illicit drug use that may interfere with patient compliance
Cytotoxic chemotherapeutic agents within 30 days of study drug administration
HIV vaccine dose within 90 days of study drug administration
History of relevant pancreatitis or hepatitis in the last 6 months
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 1 location
CompletedOne Study Center