Skip to main content
OpenTrials
Completed

NCT Number: NCT00385645

Atazanavir or Lopinavir in HIV Post-exposure Prophylaxis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Combivir+Kaletra

Drug

Combivir+Reyataz

Drug

Primary outcomes

  1. Proportions of patients completing 28-day antiretroviral treatment (ARVT)

Secondary outcomes

  1. Proportion of HIV-seropositive at 6 months

  2. Incidence of adverse effects (clinical and laboratory) during ARVT

  3. Adherence to ARVT, time to adherence loss.

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Oct 11, 2006
Registry last updated
Mar 31, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.