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Sponsored by: |
Hospital Clinic of Barcelona |
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Information provided by: | Hospital Clinic of Barcelona |
ClinicalTrials.gov Identifier: | NCT00385645 |
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 IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 240 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Felipe Garcia, MD | 34932275400 ext 2884 | fgarcia@clinic.ub.es |
Contact: Juan A Arnaiz, MD | 34932279838 | jaarnaiz@clinic.ub.es |
Spain | |
Hospital Clinic | |
Barcelona, Spain, 08036 | |
Hospital de Sant Pau | |
Barcelona, Spain, 08025 | |
Hospital Vall d'Hebron | |
Barcelona, Spain, 08035 | |
Hospital del Mar | |
Barcelona, Spain, 08003 | |
Hospital Joan XXIII | |
Tarragona, Spain, 43007 | |
Spain, Barcelona | |
Hospital Universitari Germans Trias i Pujol | |
Badalona, Barcelona, Spain, 08916 | |
Mutua de Terrassa | |
Terrassa, Barcelona, Spain, 08221 |
Principal Investigator: | Felipe Garcia, MD | Hospital Clinic, Barcelona |
Study ID Numbers: | DATEM-PEP |
Study First Received: | October 10, 2006 |
Last Updated: | January 10, 2007 |
ClinicalTrials.gov Identifier: | NCT00385645 |
Health Authority: | Spain: Spanish Agency of Medicines |
HIV seronegativity |
Virus Diseases Sexually Transmitted Diseases, Viral Lopinavir Ritonavir HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Lamivudine Atazanavir Retroviridae Infections Immunologic Deficiency Syndromes |
Anti-Infective Agents RNA Virus Infections HIV Protease Inhibitors Slow Virus Diseases Anti-HIV Agents Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Protease Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections |