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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN41611080 |
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Date of registration:
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19/01/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of two Trizivir-based strategies of induction-maintenance in antiretroviral-naive HIV-infected patients
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Scientific title:
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Date of first enrolment:
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15/04/2003 |
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Target sample size:
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220 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN41611080 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Treatment)
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Phase:
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Countries of recruitment
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Spain
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Jose
Gatell |
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Address:
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Infectious Diseases and HIV Unit
Hospital Clinic
Villarroel 170
08036
Barcelona
Spain |
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Telephone:
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+34 (0)932275430 |
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Email:
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gatell@medicina.ub.es |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Male and female
2. HIV-1 infection
3. Age 18 or above
4. Antiretroviral-naive
5. Plasma viral load above 10,000 copies/ml
6. Life expectancy >72 weeks
7. Written informed consent
Exclusion criteria: 1. Pregnancy, breastfeeding or intention to become pregnant during the study planned duration
2. Current opportunistic infection requiring parenteral therapy
3. Any formal contraindication to receive the study drugs
4. Current treatment with investigational drugs
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Human immunodeficiency virus (HIV) infection
Infections and Infestations
Human immunodeficiency virus (HIV)
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Intervention(s)
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Patients are randomly assigned to receive either:
1. Retrovir (AZT) + Lamivudine (3TC) + Trizivir (ABC) + Efavirenz (Sustiva), or
2. AZT + 3TC + ABC + Lopinavir/Ritonavir (Kaletra)
After 24 weeks, patients in both arms showing undetectable viral load will receive Trizivir for 48 more weeks.
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Primary Outcome(s)
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Proportion of patients with viral load below 20 copies/ml (polymerase chain reaction [PCR] estandar, Amplicor Monitor Roche Ultrasensible) at 72 weeks.
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Secondary Outcome(s)
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1. Proportion of patients with CD4+ cell count above 200 c/ml at 72 weeks
2. Proportion of patients with viral load <20 copies/ml at 24 weeks
3. Time to treatment failure
4. Duration of response
5. Incidence of adverse events (clinical and laboratory) leading to discontinuation of the study drugs
6. Incidence of C events (CDC 1993)
7. Death for any cause
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Source(s) of Monetary Support
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GlaxoSmithKline (GSK)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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