Completed
3TC, Abacavir, Amprenavir and Nelfinavir or Indinavir Combination Therapy for HIV Treatment in Patients Failed Initial Combination Therapy
What is being tested
Indinavir sulfate
+ Abacavir sulfate
+ Amprenavir
Drug
Who is being recruted
Blood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
Over 13 Years
+13 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Study Start: March 1999
Summary
Principal SponsorGlaxo Wellcome
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Study start date: March 1, 1999
Actual date on which the first participant was enrolled.Patients experiencing virologic failure while receiving an IDV-containing antiretroviral regimen will receive the 3TC/ABC/APV/NFV combination. Patients experiencing virologic failure while receiving an NFV-containing antiretroviral regimen will receive the 3TC/ABC/APV/IDV combination.
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
100 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
7 inclusion criteria required to participate
Agree to practice abstinence or use effective barrier methods of birth control (unless you are physically incapable of becoming pregnant)
Are 13 years of age or older
Are HIV-positive
Are currently taking anti-HIV drugs, 1 of which must be NFV or IDV, and have taken these same drugs for at least 12 weeks
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6 exclusion criteria prevent from participating
Have certain AIDS-related infections or diseases, have other serious medical conditions such as diabetes and certain types of heart trouble, or have a history of lymphoma
Have certain digestion problems that make it difficult to take anti-HIV drugs by mouth
Have ever taken the following anti-HIV drugs: ABC, APV, efavirenz (EFV), delavirdine (DLV), nevirapine (NVP), or loviride
Have had certain types of hepatitis in the past 6 months
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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
Georgetown Univ Med Ctr
Washington D.C., United StatesIDC Research Initiative
Altamonte Springs, United StatesNatl Institute of Allergy and Infectious Diseases
Bethesda, United StatesCompleted8 Study Centers