Stanford, California 94305

  • HIV Infections

Purpose:

The purpose of this study is to determine whether patients who have asymptomatic HIV infection can discontinue antiretroviral therapy (ART) without adverse clinical, virologic, or immunologic consequences. This study will also assess the virologic, immunologic, and clinical outcomes in any patients who restart ART.


Study summary:

Patients who can discontinue ART without a significant loss of virologic or immunologic control and without an increase in clinical events may be spared the expense and adverse effects of treatment. However, the consequences of treatment discontinuation in patients with asymptomatic HIV infections are not well understood. This study will follow the clinical and immunologic progression of HIV infection in patients who have low HIV viral load and preserved CD4+ cell counts at the time ART is stopped. Patients will fast for at least 8 hours prior to the first study visit. At this visit, blood will be drawn and body measurements will be taken. Patients will then discontinue their ART. Patients taking nonnucleoside reverse transcriptase inhibitors (NNRTIs) will stop taking NNRTIs 48 hours before withdrawing their other ART drugs. Study visits will occur every 4 to 8 weeks for the first year, then every 12 weeks for the second year. Blood will be taken at most visits, and patients will be asked to fast for at least 8 hours prior to Week 12 and 24 visits and again every 6 months. Patients who reinitiate ART for any reason will be registered to Step 2 and followed for 24 weeks.


Criteria:

Inclusion Criteria: - HIV infection - ART with 2 or more drugs for 6 or more months - CD4+ cell count(s) > 350 cells/mm3 immediately prior to initiation of first ART - CD4+ cell count > 350 cells/mm3 within 45 days prior to study entry - Plasma viral load < 55,000 copies/ml within 45 days prior to study entry - Willingness to discontinue ART at study entry - Negative serum or urine pregnancy test within 14 days prior to study entry Exclusion Criteria: - Pregnancy or breast-feeding - Systemic cancer chemotherapy, systemic investigational agents, or immunomodulators within 30 days prior to study entry - Drug or alcohol use or dependence that would interfere with adherence to study requirements - Illness requiring systemic treatment and/or hospitalization until the patient either completes therapy or has been clinically stable on therapy for at least 30 days prior to study entry - Chronic medical condition that would have a negative impact on the participation of the patient or would be expected to result in significant use of the medical care system - History of an HIV-related illness or complication in CDC categories B and C - Nonadherence to ART - Active infection with hepatitis B and currently taking adefovir at doses > 10 mg or 3TC and/or TDF


Study is Available At:


Original ID:

ACTG A5170


NCT ID:

NCT00050284


Secondary ID:


Study Acronym:


Brief Title:

Discontinuation of Antiretroviral Therapy in Patients With Asymptomatic HIV Infection


Official Title:

Predictors of Immunologic and Clinical Progression in Subjects With CD4+ Cell Counts Greater Than 350 Cells/mm3 Who Discontinue Antiretroviral Therapy


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

13 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute of Allergy and Infectious Diseases (NIAID)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Time Perspective: Prospective


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

158


Enrollment Type:


Overall Contact Information

Official Name:Daniel J. Skiest, M. D.
Study Chair
University of Texas Southwestern Medical Center

Study Dates

Verification Date:November 2010
Last Changed Date:November 5, 2010
First Received Date:December 3, 2002

Study Outcomes

There are no available Study Outcomes

Study Interventions

There are no available Study Interventions

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute of Allergy and Infectious Diseases (NIAID)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Le Moing V, Chene G, Leport C, Lewden C, Duran S, Garre M, Masquelier B, Dupon M, Raffi F. Impact of discontinuation of initial protease inhibitor therapy on further virological response in a cohort of human immunodeficiency virus-infected patients. Clin Infect Dis. 2002 Jan 15;34(2):239-47.
PMID:11740714
Reference Type:Reference
Citation:Mocroft A, Youle M, Moore A, Sabin CA, Madge S, Lepri AC, Tyrer M, Chaloner C, Wilson D, Loveday C, Johnson MA, Phillips AN. Reasons for modification and discontinuation of antiretrovirals: results from a single treatment centre. AIDS. 2001 Jan 26;15(2):185-94.
PMID:11216926
Reference Type:Reference
Citation:Deeks SG, Wrin T, Liegler T, Hoh R, Hayden M, Barbour JD, Hellmann NS, Petropoulos CJ, McCune JM, Hellerstein MK, Grant RM. Virologic and immunologic consequences of discontinuing combination antiretroviral-drug therapy in HIV-infected patients with detectable viremia. N Engl J Med. 2001 Feb 15;344(7):472-80.
PMID:11172188
Reference Type:Reference
Citation:Daar ES, Bai J, Hausner MA, Majchrowicz M, Tamaddon M, Giorgi JV. Acute HIV syndrome after discontinuation of antiretroviral therapy in a patient treated before seroconversion. Ann Intern Med. 1998 May 15;128(10):827-9. No abstract available.
PMID:9599194
Reference Type:Results Reference
Citation:Robertson KR, Su Z, Margolis DM, Krambrink A, Havlir DV, Evans S, Skiest DJ; For the A5170 Study Team. Neurocognitive effects of treatment interruption in stable HIV-positive patients in an observational cohort. Neurology. 2010 Mar 17; [Epub ahead of print]
PMID:20237308

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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