CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 113 enrolled
Drug / intervention
Highly active antiretroviral therapy (HAART)drug
Likely dose
Not stated in record
Key inclusion· 3
  • ✓Documented acute or recent HIV infection (infected in the past 12 months)
  • ✓Antiretroviral naive (prior PEP use allowed)
  • ✓Able to swallow tablets or capsules
Key exclusion· 8
  • ✕Physician unable to design a potentially effective HAART regimen based on genotypic resistance testing results
  • ✕Two CD4 counts <350 cells/mm³ at least 7 days apart within 30 days of entry
  • ✕Viral load <5,000 copies/mL within 30 days of entry for participants infected >6 months prior to study entry
  • ✕Use of systemic cancer chemotherapy, investigational agents, certain antiretrovirals, or immunomodulators within 30 days prior to entry

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00106171
NCT00106171Phase 4Completed
CompareCT.gov

A Randomized Trial of HAART in Acute/Early HIV Infection

Johns Hopkins Bloomberg School of Public Health·interventional·Posted Mar 22, 2005·Updated Sep 13, 2023

In Brief

A Phase 4 clinical trial evaluating Highly active antiretroviral therapy (HAART) for HIV Infections. Completed, enrolled 113 participants across 5 sites in 2 countries.

Detailed Summary

It is not known if anti-HIV treatment for recently infected patients improves long-term patient prognosis. The purpose of this study is to determine if a one year course of anti-HIV medications slows progression of HIV disease in adults recently infected with HIV. Study hypothesis: A one-year course of HAART administered during acute or early seroconversion may slow the progression of HIV infection.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesCanada, United States
CollaboratorsNational Institute of Allergy and Infectious Diseases (NIAID)

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 22, 2005
Enrollment StartMay 1, 2005
Primary CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7 yearsPosted 21.3 years ago

Interventions

Highly active antiretroviral therapy (HAART)drug

Regimens will be assigned by investigators