drugset / Trial / NCT00034086

Study of Anti-HIV Therapy Intensification

NCT00034086

Open-labelTreatment

Summary

The purpose of this study is to see how the body's immune system changes after replacing and adding new anti-HIV drugs to a patient's current anti-HIV therapy. This study will also see whether adding drugs is safe. Patients who take part in A5136 are also eligible to take part in 2 substudies. The purpose of substudy A5140s is to see how many latently infected cells (cells in which the HIV virus survives) are in the lymph node (small, rounded structures that make disease-fighting cells). Substudy A5155s will be performed to see how many latently infected cells are in the blood before and after replacing and adding anti-HIV drugs. ACTG A5136 is a follow-up study to ACTG 315 and ACTG 375, which were designed to examine the effects of highly active antiretroviral therapy (HAART) in certain HIV-infected patients. Many HIV-infected patients have undergone long-term anti-HIV therapy and have had the virus suppressed. However, most of these patients still have problems with their immune systems. The reason for these problems is unknown. This study may help researchers understand what causes immune system problems in people who have low levels of HIV in their blood.

Timeline

Start
Primary completion
Completion
2006-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Lopinavir Other / unclassified
Subject Ritonavir Other / unclassified
Subject Tenofovir disoproxil fumarate Small molecule
Background Didanosine Small molecule
Background Haemophilus b Conjugate Vaccine Vaccine
Background Lamivudine Other / unclassified
Background Lyme Disease Vaccine Recombinant OspA Vaccine
Background Pneumococcal Vaccine, Polyvalent (23-valent) Vaccine
Background Stavudine Other / unclassified
Background Zidovudine Small molecule