Atazanavir or Lopinavir in HIV Post-exposure Prophylaxis
This study has been completed.
Sponsor:
Hospital Clinic of Barcelona
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00385645
First received: October 10, 2006
Last updated: March 30, 2010
Last verified: March 2010
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Purpose
The study compares the adherence of 240 HIV-negative subjects randomly assigned to 2 different antiretroviral therapies for 28 days after accidental exposure to HIV.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: Combivir+Kaletra Drug: Combivir+Reyataz |
Phase 4 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
Official Title: | Comparison of 2 Alternative Antiretroviral Combinations in HIV Post-exposure Prophylaxis: AZT-3TC (Combivir®) + Lopinavir-ritonavir (Kaletra®) Versus AZT-3TC (Combivir®)+ Atazanavir (Reyataz®). Multicentre, Prospective, Randomized, Open Study |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by Hospital Clinic of Barcelona:
Primary Outcome Measures:
- Proportions of patients completing 28-day antiretroviral treatment (ARVT)
Secondary Outcome Measures:
- Proportion of HIV-seropositive at 6 months
- Incidence of adverse effects (clinical and laboratory) during ARVT
- Adherence to ARVT, time to adherence loss.
Enrollment: | 255 |
Study Start Date: | May 2006 |
Study Completion Date: | August 2009 |
Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Eligibility
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age > 18
- HIV exposure requiring prophylaxis under current guidelines
Exclusion Criteria:
- Pregnancy
- Suspected drug resistance in source case
- Contraindications to the study drugs
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00385645
Locations
Spain | |
Hospital Universitari Germans Trias i Pujol | |
Badalona, Barcelona, Spain, 08916 | |
Mutua de Terrassa | |
Terrassa, Barcelona, Spain, 08221 | |
Hospital Clinic | |
Barcelona, Spain, 08036 | |
Hospital de Sant Pau | |
Barcelona, Spain, 08025 | |
Hospital del Mar | |
Barcelona, Spain, 08003 | |
Hospital Vall d'Hebron | |
Barcelona, Spain, 08035 | |
Hospital Joan XXIII | |
Tarragona, Spain, 43007 |
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
Principal Investigator: | Felipe Garcia, MD | Hospital Clinic, Barcelona |
More Information
No publications provided by Hospital Clinic of Barcelona
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Keywords provided by Hospital Clinic of Barcelona:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 14, 2013
No publications provided by Hospital Clinic of Barcelona
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Felipe Garcia Alcaide, Hospital Clinic of Barcelona |
ClinicalTrials.gov Identifier: | NCT00385645 History of Changes |
Other Study ID Numbers: | DATEM-PEP |
Study First Received: | October 10, 2006 |
Last Updated: | March 30, 2010 |
Health Authority: | Spain: Spanish Agency of Medicines |
Keywords provided by Hospital Clinic of Barcelona:
HIV seronegativity |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Lamivudine, zidovudine drug combination Lopinavir |
Atazanavir Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents HIV Protease Inhibitors Protease Inhibitors |
ClinicalTrials.gov processed this record on March 14, 2013