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Study of Anti-HIV Therapy Intensification

NCT00034086 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2012-05-18

No results posted yet for this study

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.

Conditions

  • HIV Infections

Interventions

DRUG

Lopinavir/Ritonavir

DRUG

Lamivudine/Zidovudine

DRUG

Tenofovir disoproxil fumarate

BIOLOGICAL

Pneumococcal Vaccine, Polyvalent (23-valent)

DRUG

Lamivudine

DRUG

Stavudine

DRUG

Zidovudine

DRUG

Didanosine

BIOLOGICAL

Lyme Disease Vaccine Recombinant OspA

BIOLOGICAL

Haemophilus B Conjugate Vaccine

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Kimberly Smith

  • Hernan Valdez

Study Design

Purpose
TREATMENT
Masking
NONE

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Completion
2006-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00034086 on ClinicalTrials.gov