Clinical trial NCT00000840: A Multicenter, Exploratory Study to Evaluate the Effects of Antiretroviral Cessation on Plasma Associated HIV-1 RNA
Official title: A Multicenter, Exploratory Study to Evaluate the Effects of Antiretroviral Cessation on Plasma Associated HIV-1 RNA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Antiviral Agents
Zidovudine
Biological Markers
Viremia
RNA, Viral
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2001-08-31
Enrollment: 70
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: NATURAL_HISTORY

Brief summary: To evaluate viral load in the blood stream of HIV-infected patients during a 28-day washout following cessation of long-term zidovudine ( AZT ) therapy.

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria

Concurrent Medication:

Allowed:

* Maintenance therapy for opportunistic infection, provided patient has received at least 1 month of stable therapy prior to study.
* G-CSF.

Patients must have:

* HIV infection.
* CD4 count \<= 500 cells/mm3.
* At least 12 months of prior AZT, with 2 months of continuous AZT monotherapy immediately prior to study.
* The need to discontinue AZT because of drug-related toxicity or unwanted side effects or as an entry requirement for another research study.
* Consent of parent or guardian if \< 18 years old.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Current medical status that is considered unsuitable for study participation.

Concurrent Medication:

Excluded:

* Therapy for an acute opportunistic infection.

Prior Medication:

Excluded within the past 2 months:

* Antiretrovirals other than AZT.
* Systemic immunomodulators (e.g., gp120, gp160, IL-2, and interferons).

Excluded within the past month:

* Vaccination.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Univ Med School
state: Illinois
city: Chicago
country: United States
facility: Rush Presbyterian - Saint Luke's Med Ctr
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins Hosp
state: Maryland
city: Buffalo
country: United States
facility: SUNY / Erie County Med Ctr at Buffalo
state: New York
city: Rochester
country: United States
facility: Univ of Rochester Medical Center
state: New York
city: Cleveland
country: United States
facility: Case Western Reserve Univ
state: Ohio
city: Columbus
country: United States
facility: Ohio State Univ Hosp Clinic
state: Ohio
city: Seattle
country: United States
facility: Univ of Washington
state: Washington
Study officials:
name: Para MF
role: STUDY_CHAIR
name: Demeter L
role: STUDY_CHAIR
References: