Evaluation and Monitoring of Patients With HIV Infectionn
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | February 1995 |
Clinical, Virologic, and Immunologic Evaluation and Monitoring of Patients With Known or Suspected HIV Infection
This study is designed to learn more about HIV infection and the conditions associated with
it.
Patients 18 years of age or older with known or suspected HIV infection may be eligible for
this study. Patients may have participated in previous NIH studies.
Participants will have periodic physical examinations and blood tests, including evaluations
for responses to treatment. Treatment consistent with accepted standard medical practice
will be individualized for each patient. Patients who previously participated in a NIH study
will be followed for possible long-term benefits or side effects of treatment. Patients
treated with alpha-interferon or interleukin-2 (IL-2) may continue treatment with that
medication if it is felt that they might benefit from it. Blood samples may be drawn as part
of standard medical care and for research purposes. Other tests may be done as appropriate
for diagnosis and treatment, including, for example, a chest X-ray, electrocardiogram, or
tissue biopsy. Patients will be seen for follow-up visits at regular intervals to monitor
treatment progress.
Certain patients currently enrolled in a NIH study of IL-2 treatment may participate in a
phase of the study that adds a corticosteroid, such as hydrocortisone, prednisone, or
prednisonolone, to the regimen. Patients whose CD4 counts did not increase with IL-2 will
receive corticosteroids (by mouth or by vein) in an open manner. Patients who responded to
IL-2 therapy will be randomly assigned to receive corticosteroids or a placebo (inactive
substance) during IL-2 infusions in a blinded manner, so that neither the patient nor the
medical staff will know which patients are receiving the drug and which are receiving a
placebo. Participants will be requested to receive at least three rounds of treatment with
corticosteroid or placebo.
Patients currently taking IL-2 by subcutaneous injection (under the skin) may participate in
an optional part of the study to receive future IL-2 cycles at home instead of at or near
the Clinical Center. Patients who have shown an ability to self-administer and tolerate IL-2
injections with minimal supervision and minimal side effects may be eligible for this
option. Home administration of IL-2 involves less frequent data and safety monitoring, and
no on-site medical evaluation at the very beginning of each cycle. Participants will
continue to be seen at the Clinical Center for regularly scheduled follow-up visits and
medical evaluations before the start of each IL-2 cycle to determine if it is safe to begin
that cycle. Patients will have a case manager who will place monitoring calls on days 2 and
4 of the cycle and a third follow-up call 1 week later. Patients will be responsible for
contacting a study staff member if complications of other problems develop at other times.
it.
Patients 18 years of age or older with known or suspected HIV infection may be eligible for
this study. Patients may have participated in previous NIH studies.
Participants will have periodic physical examinations and blood tests, including evaluations
for responses to treatment. Treatment consistent with accepted standard medical practice
will be individualized for each patient. Patients who previously participated in a NIH study
will be followed for possible long-term benefits or side effects of treatment. Patients
treated with alpha-interferon or interleukin-2 (IL-2) may continue treatment with that
medication if it is felt that they might benefit from it. Blood samples may be drawn as part
of standard medical care and for research purposes. Other tests may be done as appropriate
for diagnosis and treatment, including, for example, a chest X-ray, electrocardiogram, or
tissue biopsy. Patients will be seen for follow-up visits at regular intervals to monitor
treatment progress.
Certain patients currently enrolled in a NIH study of IL-2 treatment may participate in a
phase of the study that adds a corticosteroid, such as hydrocortisone, prednisone, or
prednisonolone, to the regimen. Patients whose CD4 counts did not increase with IL-2 will
receive corticosteroids (by mouth or by vein) in an open manner. Patients who responded to
IL-2 therapy will be randomly assigned to receive corticosteroids or a placebo (inactive
substance) during IL-2 infusions in a blinded manner, so that neither the patient nor the
medical staff will know which patients are receiving the drug and which are receiving a
placebo. Participants will be requested to receive at least three rounds of treatment with
corticosteroid or placebo.
Patients currently taking IL-2 by subcutaneous injection (under the skin) may participate in
an optional part of the study to receive future IL-2 cycles at home instead of at or near
the Clinical Center. Patients who have shown an ability to self-administer and tolerate IL-2
injections with minimal supervision and minimal side effects may be eligible for this
option. Home administration of IL-2 involves less frequent data and safety monitoring, and
no on-site medical evaluation at the very beginning of each cycle. Participants will
continue to be seen at the Clinical Center for regularly scheduled follow-up visits and
medical evaluations before the start of each IL-2 cycle to determine if it is safe to begin
that cycle. Patients will have a case manager who will place monitoring calls on days 2 and
4 of the cycle and a third follow-up call 1 week later. Patients will be responsible for
contacting a study staff member if complications of other problems develop at other times.
This study is designed as a prospective, observational and treatment study, with ongoing
monitoring of the progression of HIV infection and HIV-related disease processes. A data
base, not otherwise obtainable, will be collected of unusual disease processes related to
HIV infection, and of the long-term effects of experimental treatments that patients may
have received under earlier protocols for HIV and related infections. Up to 500 patients
with known or suspected HIV-infection will be enrolled. Minimal studies scheduled for each
visit will include monitoring of immune status, routine safety laboratory tests, and
evaluation for possible opportunistic infections. Treatment plans will be individualized for
each patient's particular condition, and the number and length of additional visits and
diagnostic evaluations will vary accordingly. Specific treatment regimens will be in
accordance with standard medical practice.
monitoring of the progression of HIV infection and HIV-related disease processes. A data
base, not otherwise obtainable, will be collected of unusual disease processes related to
HIV infection, and of the long-term effects of experimental treatments that patients may
have received under earlier protocols for HIV and related infections. Up to 500 patients
with known or suspected HIV-infection will be enrolled. Minimal studies scheduled for each
visit will include monitoring of immune status, routine safety laboratory tests, and
evaluation for possible opportunistic infections. Treatment plans will be individualized for
each patient's particular condition, and the number and length of additional visits and
diagnostic evaluations will vary accordingly. Specific treatment regimens will be in
accordance with standard medical practice.
- INCLUSION CRITERIA:
HIV-infection, as documented by positive HIV ELISA and Western Blot. Patients may also be
included if they have laboratory or clinical evidence suggestive of possible
HIV-infection.
Age 18 years or older.
Ability to give written, informed consent.
CD4 cell count of any level.
Patients may be receiving anti-retroviral therapy, and any medications provided by their
primary physician for the treatment of HIV and its complications.
Patients who lack primary medical care outside the NIH may be enrolled in this protocol.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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