Atazanavir or Lopinavir in HIV Post-exposure Prophylaxis

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00385645

Enrollment

255

Registered

2006-10-11

Start date

2006-05-31

Completion date

2009-08-31

Last updated

2010-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

HIV seronegativity

Brief summary

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.

Interventions

DRUGCombivir+Kaletra

DRUGCombivir+Reyataz

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Proportions of patients completing 28-day antiretroviral treatment (ARVT)	—

Secondary

Measure	Time frame
Proportion of HIV-seropositive at 6 months	—
Incidence of adverse effects (clinical and laboratory) during ARVT	—
Adherence to ARVT, time to adherence loss.	—

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026