HIV InfectionsNCT00050284
Discontinuation of Antiretroviral Therapy in Patients With Asymptomatic HIV Infection
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 34 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections
- How many people
- 158 participants
- Where
- 34 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
Univ of North Carolina
Chapel Hill, North Carolina, 27514
Northwestern Univ
Chicago, Illinois, 60611-3015
Cook County Hosp Core Ctr
Chicago, Illinois, 60612
Rush-Presbyterian / St.Lukes (Chicago)
Chicago, Illinois, 60612
Univ of Cincinnati
Cincinnati, Ohio, 45267-0405
Univ of Texas, Southwestern Medical Ctr
Dallas, Texas, 75235
Duke Univ Med Ctr
Durham, North Carolina, 27710
Univ of Hawaii
Honolulu, Hawaii, 96816
Indiana Univ Hosp
Indianapolis, Indiana, 46202
Methodist Hosp of Indiana
Indianapolis, Indiana, 46202
Wishard Hosp
Indianapolis, Indiana, 46202
Univ of Southern California
Los Angeles, California, 90033-1079
Univ of Minnesota
Minneapolis, Minnesota, 55455-0392
Comprehensive Care Clinic
Nashville, Tennessee, 37203
Beth Israel Med Ctr
New York, New York, 10003
NYU/Bellevue
New York, New York, 10016-6481
Chelsea Clinic
New York, New York, 1001
The Cornell Clinical Trials Unit
New York, New York, 10021
Presbyterian Med Ctr- Univ of PA
Norristown, Pennsylvania, 19401
Univ of Pennsylvania, Philadelphia
Philadelphia, Pennsylvania, 19104
Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15213-2582
Rhode Island Hosp
Providence, Rhode Island, 02906
Stanley Street Treatment and Resource
Providence, Rhode Island, 02906
The Miriam Hospital
Providence, Rhode Island, 02906
Univ of California, San Diego Antiviral Research Ctr
San Diego, California, 92103
Univ of California San Francisco
San Francisco, California, 94110
St. Louis Connect Care
St Louis, Missouri, 63108-2138
Washington Univ (St. Louis)
St Louis, Missouri, 63108-2138
San Mateo County AIDS Program
Stanford, California, 94305
Santa Clara Valley Med Ctr
Stanford, California, 94305
Stanford Univ
Stanford, California, 94305
Willow Clinic
Stanford, California, 94305
Harbor General/UCLA
Torrance, California, 90502-2052
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
About this study
Official title: Predictors of Immunologic and Clinical Progression in Subjects With CD4+ Cell Counts Greater Than 350 Cells/mm3 Who Discontinue Antiretroviral Therapy
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.
Read the detailed 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.
- Conditions
- HIV Infections
- Keywords
- Treatment Experienced, Disease Progression, Anti-HIV Agents, Treatment Interruption
- Medical subject headings
- HIV Infections, Disease Progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2002 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 158 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Daniel J. Skiest, M. D., Study chair, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00050284
- Sponsor's protocol ID
- ACTG A5170
- Status last verified
- Nov 2010
- First submitted
- 3 Dec 2002
- Last updated
- 9 Nov 2010
- Results posted
- No
Publications
Le Moing V, Chene G, Leport C, Lewden C, Duran S, Garre M, Masquelier B, Dupon M, Raffi F; Antiproteases 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. doi: 10.1086/324354. Epub 2001 Dec 4.
PubMed 11740714Mocroft 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. doi: 10.1097/00002030-200101260-00007.
PubMed 11216926Deeks 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. doi: 10.1056/NEJM200102153440702.
PubMed 11172188Daar 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. doi: 10.7326/0003-4819-128-10-199805150-00005. No abstract available.
PubMed 9599194Robertson 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/WNL.0b013e3181d9ed09. Epub 2010 Mar 17.
PubMed 20237308
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Immunologic and Clinical Progression in Subjects With CD4+ Cell Counts Greater Than 350 Cells/mm3 Who Discontinue Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT00050284
- Acronym / sponsor ID
- ACTG A5170
- Conditions
- HIV Infections
- Keywords
- Treatment Experienced, Disease Progression, Anti-HIV Agents, Treatment Interruption
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- First posted
- 4 Dec 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2010.
- Background: PubMed 11740714Le Moing V, Chene G, Leport C, Lewden C, Duran S, Garre M, Masquelier B, Dupon M, Raffi F; Antiproteases 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. doi: 10.1086/324354. Epub 2001 Dec 4.
- Background: PubMed 11216926Mocroft 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. doi: 10.1097/00002030-200101260-00007.
- Background: PubMed 11172188Deeks 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. doi: 10.1056/NEJM200102153440702.
- Background: PubMed 9599194Daar 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. doi: 10.7326/0003-4819-128-10-199805150-00005. No abstract available.
- Results publication: PubMed 20237308Robertson 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/WNL.0b013e3181d9ed09. Epub 2010 Mar 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel J. Skiest, M. D. study chair
University of Texas Southwestern Medical Center
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 34 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00050284, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2010.