Completed

Effects of Antiretroviral Cessation on Plasma Associated HIV-1 RNA

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study Aim

This observational study aims to investigate how stopping antiretroviral treatment affects the levels of HIV-1 RNA in your plasma.

What is being collected

Data Collection

Who is being recruted

Blood-Borne Infections+20

+ Urogenital Diseases

+ Genital Diseases

Over 13 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Natural History

Observing the progression of a disease in untreated individuals in order to understand its typical course and outcomes.
Observational
See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Because viral load (amount of HIV RNA in the plasma) is often used as a measure of the effectiveness of new antiretroviral drugs in clinical trials, a washout period, or cessation of current antiretroviral regimens, is commonly required for study entry to allow for a drug-free steady state of viral load prior to initiation of the new drug. However, the kinetics of the viral rebound following drug withdrawal has not been sufficiently studied, and the proper duration of washout is an estimate. Patients who have volunteered to temporarily cease antiretroviral therapy will be followed during a 28-day washout period. Blood samples are drawn at each of nine clinic visits. Patients may resume antiretrovirals after the 28-day washout.

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

70 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Natural History

These studies observe how a disease progresses over time without active treatment. They help researchers understand how conditions typically develop, change, and impact quality of life.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 13 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsInflammationPathologic ProcessesRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesPathological Conditions, Signs and SymptomsVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsSystemic Inflammatory Response SyndromeSepsisAcquired Immunodeficiency SyndromeAIDS-Related ComplexViremiaHIV Infections

Criteria

6 inclusion criteria required to participate
Allowed concurrent medication includes maintenance therapy for opportunistic infection, provided patient has received at least 1 month of stable therapy prior to study and G-CSF

Consent of parent or guardian if < 18 years old

Patients must have CD4 count <= 500 cells/mm3

Patients must have HIV infection

Show More Criteria

4 exclusion criteria prevent from participating
Excluded concurrent medication includes therapy for an acute opportunistic infection

Excluded prior medication within the past 2 months includes antiretrovirals other than AZT and systemic immunomodulators (e.g., gp120, gp160, IL-2, and interferons)

Excluded prior medication within the past month includes vaccination

Patients with current medical status that is considered unsuitable for study participation are excluded

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 8 locations

Northwestern Univ Med School

Chicago, United StatesOpen Northwestern Univ Med School in Google Maps

Rush Presbyterian - Saint Luke's Med Ctr

Chicago, United States

Johns Hopkins Hosp

Baltimore, United States

SUNY / Erie County Med Ctr at Buffalo

Buffalo, United States
Completed8 Study Centers