Atazanavir or Lopinavir in HIV Post-exposure Prophylaxis
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ClinicalTrials.gov Identifier: NCT00385645 |
Recruitment Status
:
Completed
First Posted
: October 11, 2006
Last Update Posted
: March 31, 2010
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Combivir+Kaletra Drug: Combivir+Reyataz | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 255 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | May 2006 |
Actual Primary Completion Date : | August 2009 |
Actual Study Completion Date : | August 2009 |

- Proportions of patients completing 28-day antiretroviral treatment (ARVT)
- Proportion of HIV-seropositive at 6 months
- Incidence of adverse effects (clinical and laboratory) during ARVT
- Adherence to ARVT, time to adherence loss.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00385645
Spain | |
Hospital Universitari Germans Trias i Pujol | |
Badalona, Barcelona, Spain, 08916 | |
Mutua de Terrassa | |
Terrassa, Barcelona, Spain, 08221 | |
Hospital del Mar | |
Barcelona, Spain, 08003 | |
Hospital de Sant Pau | |
Barcelona, Spain, 08025 | |
Hospital Vall d'Hebron | |
Barcelona, Spain, 08035 | |
Hospital Clinic | |
Barcelona, Spain, 08036 | |
Hospital Joan XXIII | |
Tarragona, Spain, 43007 |
Principal Investigator: | Felipe Garcia, MD | Hospital Clinic of Barcelona |
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 |
First Posted: | October 11, 2006 Key Record Dates |
Last Update Posted: | March 31, 2010 |
Last Verified: | March 2010 |
Keywords provided by Hospital Clinic of Barcelona:
HIV seronegativity |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Lopinavir Atazanavir Sulfate Lamivudine, zidovudine drug combination Zidovudine Lamivudine |
HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Antimetabolites |