CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Lamivudine +4 moredrug
Likely dose
Lamivudine 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00100646
NCT00100646N/ACompleted

A Randomized Clinical Trial Assessing Continuous HAART Versus Interrupted HAART in a Resource Poor Clinic

The Wistar Institute·interventional·Posted Jan 5, 2005·Updated Aug 27, 2014

In Brief

A clinical study evaluating Structured treatment interruption, Lamivudine, and 3 other interventions for HIV Infections. Completed, enrolled 30 participants across 1 site.

Detailed Summary

HIV infected people often must take anti-HIV drugs for long periods, leading to long-term drug exposure and toxicity. Interruptions in anti-HIV therapy, also known as structured treatment interruptions (STIs), may have few negative health effects and may be helpful to the overall long-term health of HIV-infected people. The purpose of this study is to determine if sequential short-term STIs of antiretroviral therapy (ART) in HIV infected individuals in a resource-constrained environment can retain the immune reconstitution benefits of continuous treatment while potentially lessening rates of toxicity associated with continuous therapy strategies and at the same time, lessen costs associated with ART.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesSouth Africa
Collaborators--

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 5, 2005
Enrollment StartMar 1, 2007
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 21.5 years ago

Interventions

Structured treatment interruptionbehavioral

Interruptions in treatment will last 2, 4, and 8 weeks in between 16-week periods of ART

Lamivudinedrug

300 mg tablet taken orally daily

Lopinavir/Ritonavirdrug

400 mg lopinavir/100 mg ritonavir tablet taken orally twice daily

Stavudinedrug

Dosage dependent on weight

Rabies de novo antigenbiological

Vaccine injected intramuscularly