Immune and Viral Status of HIV-Infected Patients After Stopping Combination Antiretroviral Therapy

• Register: ClinicalTrials.gov
• Last refreshed on: 15 April 2013
• Main ID: NCT00001899
• Date of registration: 03/11/1999
• Primary sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Public title: Immune and Viral Status of HIV-Infected Patients After Stopping Combination Antiretroviral Therapy
• Scientific title: Immunologic and Virologic Characterization of HIV-Infected Patients After Cessation of Highly Active Antiretroviral Therapy (HAART)
• Date of first enrolment: December 1998
• Target sample size: 38
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00001899
• Study type: Observational
• Study design: N/A

Countries of recruitment

United States

Contacts

• Name: Bernadette R Gochuico, M.D.
• Affiliation: National Human Genome Research Institute (NHGRI)

Key inclusion & exclusion criteria

- INCLUSION CRITERIA:

Subjects greater than or equal to 18 years of age.

HIV infection confirmed by ELISA and Western blot.

Ability to sign informed consent and willingness to comply with study requirements and
clinic policies.

In the judgment of the PI, patient has satisfactory knowledge of the benefits of
continuing HAART as well as the risks of discontinuing such treatment. The patient has a
private physician and the decision to interrupt antiretroviral therapy, the target point
(i.e. viral load or CD4+ T cell count) to reinitiate therapy, and the regiment of
antiretrovirals used upon re-initiation of therapy will be made with this private
physician.

History of at least 2 months of ongoing HAART, defined as a minimum three drug regimen
consisting of at least two nucleoside analogs and one protease inhibitor or two nucleoside
analogs and one NNRTI or three nucleosides in place of other drug classes OR patients that
are currently off therapy who are planning on resuming or initiating a HAART regimen
within the next 3 months.

No baseline CD4 counts greater than or equal to 350 cells/microL, with confirmation,
within the last 3 months.

Asymptomatic for significant HIV-related illnesses, such as opportunistic infections and
malignancies other than mucocutaneous Kaposi's sarcoma.

For patients on IL-2 therapy, agreement to resume HAART while undergoing treatment cycles.

EXCLUSION CRITERIA:

Psychiatric illness that, in the opinion of the PI, might interfere with study compliance.

Active substance abuse or history of prior substance abuse that may interfere with
protocol compliance or compromise patient safety.

Women who are pregnant or breastfeeding.

Creatinine greater than 2.

Liver function tests greater than 5 times the normal laboratory values.

Platelet count less than 100,000/mm(3), hemoglobin less than 9 mg/dL, neutrophils less
than 750/mm(3).

PT or PTT (in the absence of documented anti-cardiolipin antibody) prolonged by greater
than 2 seconds.

Known underlying bleeding disorder.

Significant cardiac, pulmonary, kidney, rheumatologic, gastrointestinal, or CNS disease as
detectable on routine history, physical examination, or screening laboratory studies.

History of significant opportunistic infection or HIV-associated malignancy.

Patient must not ever have had a total CD4 count of less than or equal to 150 cells/cubic
millimeter during the year prior to enrollment. At least 2 measurements, possibly
including the measurement during the screening visit and/or H& P visit, must be available.

Due to a possible increased risk of a hypersensitivity reaction, patients on an
abacavir-containing regimen will not be eligible for treatment interruption.

Patients with chronic hepatitis B infection receiving treatment with 3TC (lamivudine),
adefovir, or tenofovir for suppresion are not eligible for this study.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infection

Secondary ID(s)

99-I-0015

990015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors