The Effects of Anti-HIV Drugs in HIV-Infected Patients Who Do Not Have AIDS
A Multicenter, Open-Label Study of Viral Burden in Peripheral Blood Versus Lymphoid Tissue Before and After Antiretroviral Therapy in HIV-Infected Individuals Without AIDS (NOTE: One Arm Receives no Treatment)
2 other identifiers
interventional
32
1 country
8
Brief Summary
Immunopathogenesis objectives: To compare and quantitatively determine HIV burden and HIV replication in peripheral blood (PB) and lymphoid tissue (LT). To determine the degree to which antiretroviral therapy alters HIV replication in LT. Clinical objectives: To gain insight into the degree of correlation between immunologic surrogate markers for HIV disease (e.g., CD4, beta-2 microglobulin) as compared to measures of HIV replication in PB and LT. To assess changes in PB and LT viral burden after antiretroviral therapy and to determine its ability to predict an antiviral response. One of the major problems in defining the immunopathogenic changes in HIV infections has been the inability to correlate the extent of loss of immunologic function with the number of HIV-infected CD4+ cells in the peripheral blood. Few studies exist that measure viral burden in lymph nodes of HIV-infected individuals. Researchers hope to find out whether the amount of HIV virus or markers for the virus in the body's lymph tissue is a better measure of disease progression than the amount of virus or markers for the virus in the blood.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hiv-infections
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2002
CompletedNovember 1, 2021
October 1, 2021
November 2, 1999
October 28, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- Allowed:
- Chemoprophylaxis against M. tuberculosis, therapy for oral candidiasis, and short courses (up to 10 days) of acyclovir for herpes lesions.
- Antibiotics as clinically indicated.
- Pneumococcal vaccine and hepatitis B vaccine as medically indicated.
- Regularly prescribed medications such as antipyretics, analgesics, allergy medications, antidepressants, sleep medications, oral contraceptives, or other medications deemed appropriate by the patient's primary care provider.
- Recommended:
- PCP prophylaxis if patient's CD4 count falls below 200 cells/mm3 during the study.
- Concurrent Treatment:
- Allowed:
- Alternative therapies such as vitamins and acupuncture.
- Patients must have:
- Documented HIV infection.
- At least two palpable lymph nodes above the waist.
- CD4 counts \>= 350 cells/mm3 (if previously antiretroviral-naive) or \>= 250 cells/mm3 (if receiving ongoing AZT therapy).
- +4 more criteria
You may not qualify if:
- Co-existing Condition:
- Patients with the following symptoms and conditions are excluded:
- Severe malabsorption.
- Current AIDS-related opportunistic infection, AIDS dementia, AIDS-wasting syndrome, or an AIDS-related malignancy other than minimal Kaposi's sarcoma disease.
- Current medical problems that may interfere with the evaluation of AZT or increase the potential toxicity of AZT (e.g., significant liver disease, diabetes, significant cardiovascular disease, seizure disorders, lymphoma, acute or chronic pancreatitis, or febrile illness).
- Current diagnosis of malignancy for which systemic therapy would be required during study.
- Concurrent Medication:
- Excluded:
- Ganciclovir, foscarnet, chronic acyclovir, or probenecid.
- Other proven or alleged antiretroviral or anti-HIV drugs.
- Biologic response modifiers.
- Valproic acid.
- Systemic cytotoxic chemotherapy.
- Steroids.
- Concurrent Treatment:
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)lead
- Bristol-Myers Squibbcollaborator
- Glaxo Wellcomecollaborator
Study Sites (8)
Palo Alto Veterans Affairs Health Care System
Palo Alto, California, 94304, United States
Kaiser Permanente Med Ctr
San Francisco, California, 94115, United States
Mount Zion Med Ctr / UCSF
San Francisco, California, 94115, United States
Univ of Illinois
Chicago, Illinois, 60612, United States
Univ of Maryland at Baltimore
Baltimore, Maryland, 21201, United States
SUNY / Health Sciences Ctr at Stony Brook
Stony Brook, New York, 117948153, United States
Duke Univ Med Ctr
Durham, North Carolina, 27710, United States
Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15261, United States
Related Publications (1)
Cohen OJ, Pantaleo G, Graziosi C, Niu M, Fauci AS. Effect of antiretroviral therapy on HIV burden and replication in lymphoid tissue. DATRI 003 Study Group. Int Conf AIDS. 1994 Aug 7-12;10(1):7 (abstract no 001B)
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
J Cohn
- STUDY CHAIR
M Niu
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Purpose
- TREATMENT
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
June 1, 2002
Last Updated
November 1, 2021
Record last verified: 2021-10