Discontinuation of Antiretroviral Therapy in Patients With Asymptomatic HIV Infection
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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.
| Condition |
|---|
|
HIV Infections |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Predictors of Immunologic and Clinical Progression in Subjects With CD4+ Cell Counts Greater Than 350 Cells/mm3 Who Discontinue Antiretroviral Therapy |
| Estimated Enrollment: | 158 |
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.
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Hide Study Locations| United States, California | |
| Univ of Southern California | |
| Los Angeles, California, United States, 90033-1079 | |
| Univ of California, San Diego Antiviral Research Ctr | |
| San Diego, California, United States, 92103 | |
| Univ of California San Francisco | |
| San Francisco, California, United States, 94110 | |
| Santa Clara Valley Med Ctr | |
| Stanford, California, United States, 94305 | |
| Stanford Univ | |
| Stanford, California, United States, 94305 | |
| San Mateo County AIDS Program | |
| Stanford, California, United States, 94305 | |
| Willow Clinic | |
| Stanford, California, United States, 94305 | |
| Harbor General/UCLA | |
| Torrance, California, United States, 90502-2052 | |
| United States, District of Columbia | |
| Georgetown Univ Med Ctr | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Hawaii | |
| Univ of Hawaii | |
| Honolulu, Hawaii, United States, 96816 | |
| United States, Illinois | |
| Rush-Presbyterian / St.Lukes (Chicago) | |
| Chicago, Illinois, United States, 60612 | |
| Cook County Hosp Core Ctr | |
| Chicago, Illinois, United States, 60612 | |
| Northwestern Univ | |
| Chicago, Illinois, United States, 60611-3015 | |
| United States, Indiana | |
| Indiana Univ Hosp | |
| Indianapolis, Indiana, United States, 46202 | |
| Methodist Hosp of Indiana | |
| Indianapolis, Indiana, United States, 46202 | |
| Wishard Hosp | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Minnesota | |
| Univ of Minnesota | |
| Minneapolis, Minnesota, United States, 55455-0392 | |
| United States, Missouri | |
| Washington Univ (St. Louis) | |
| St. Louis, Missouri, United States, 63108-2138 | |
| St. Louis Connect Care | |
| St. Louis, Missouri, United States, 63108-2138 | |
| United States, New York | |
| The Cornell Clinical Trials Unit | |
| New York, New York, United States, 10021 | |
| Chelsea Clinic | |
| New York, New York, United States, 1001 | |
| Beth Israel Med Ctr | |
| New York, New York, United States, 10003 | |
| NYU/Bellevue | |
| New York, New York, United States, 10016-6481 | |
| United States, North Carolina | |
| Univ of North Carolina | |
| Chapel Hill, North Carolina, United States, 27514 | |
| Duke Univ Med Ctr | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Univ of Cincinnati | |
| Cincinnati, Ohio, United States, 45267-0405 | |
| United States, Pennsylvania | |
| Presbyterian Med Ctr- Univ of PA | |
| Norristown, Pennsylvania, United States, 19401 | |
| Univ of Pennsylvania, Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Univ of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213-2582 | |
| United States, Rhode Island | |
| The Miriam Hospital | |
| Providence, Rhode Island, United States, 02906 | |
| Rhode Island Hosp | |
| Providence, Rhode Island, United States, 02906 | |
| Stanley Street Treatment and Resource | |
| Providence, Rhode Island, United States, 02906 | |
| United States, Tennessee | |
| Comprehensive Care Clinic | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Univ of Texas, Southwestern Medical Ctr | |
| Dallas, Texas, United States, 75235 | |
| Study Chair: | Daniel J. Skiest, M. D. | University of Texas Southwestern Medical Center |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00050284 History of Changes |
| Other Study ID Numbers: | ACTG A5170 |
| Study First Received: | December 3, 2002 |
| Last Updated: | November 5, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
Treatment Experienced Disease Progression Anti-HIV Agents Treatment Interruption |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on May 22, 2013