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NCT00050284 Clinical Trial

Discontinuation of Antiretroviral Therapy in Patients With Asymptomatic HIV Infection

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00050284
Other study ID # ACTG A5170
Secondary ID
Status Completed
Phase N/A
First received December 3, 2002
Last updated November 5, 2010

Study information
Verified date November 2010
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 158
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 13 Years and older
Eligibility 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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Univ of North Carolina Chapel Hill North Carolina
United States Cook County Hosp Core Ctr Chicago Illinois
United States Northwestern Univ Chicago Illinois
United States Rush-Presbyterian / St.Lukes (Chicago) Chicago Illinois
United States Univ of Cincinnati Cincinnati Ohio
United States Univ of Texas, Southwestern Medical Ctr Dallas Texas
United States Duke Univ Med Ctr Durham North Carolina
United States Univ of Hawaii Honolulu Hawaii
United States Indiana Univ Hosp Indianapolis Indiana
United States Methodist Hosp of Indiana Indianapolis Indiana
United States Wishard Hosp Indianapolis Indiana
United States Univ of Southern California Los Angeles California
United States Univ of Minnesota Minneapolis Minnesota
United States Comprehensive Care Clinic Nashville Tennessee
United States Beth Israel Med Ctr New York New York
United States Chelsea Clinic New York New York
United States NYU/Bellevue New York New York
United States The Cornell Clinical Trials Unit New York New York
United States Presbyterian Med Ctr- Univ of PA Norristown Pennsylvania
United States Univ of Pennsylvania, Philadelphia Philadelphia Pennsylvania
United States Univ of Pittsburgh Pittsburgh Pennsylvania
United States Rhode Island Hosp Providence Rhode Island
United States Stanley Street Treatment and Resource Providence Rhode Island
United States The Miriam Hospital Providence Rhode Island
United States Univ of California, San Diego Antiviral Research Ctr San Diego California
United States Univ of California San Francisco San Francisco California
United States St. Louis Connect Care St. Louis Missouri
United States Washington Univ (St. Louis) St. Louis Missouri
United States San Mateo County AIDS Program Stanford California
United States Santa Clara Valley Med Ctr Stanford California
United States Stanford Univ Stanford California
United States Willow Clinic Stanford California
United States Harbor General/UCLA Torrance California
United States Georgetown Univ Med Ctr Washington District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View Citation

Le Moing V, Chêne G, Leport C, Lewden C, Duran S, Garré M, Masquelier B, Dupon M, Raffi F; Antiprotéases Cohorte (APROCO) Study Group. 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. Epub 2001 Dec 4. — View 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. — View Citation

Robertson KR, Su Z, Margolis DM, Krambrink A, Havlir DV, Evans S, Skiest DJ; A5170 Study Team. Neurocognitive effects of treatment interruption in stable HIV-positive patients in an observational cohort. Neurology. 2010 Apr 20;74(16):1260-6. doi: 10.1212/ — View Citation

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