Vaccine Therapy, Incomplete Freund's Adjuvant, and GM-CSF in Treating Patients With HIV (NCT00381875) | Clinical Trial Compass
CompletedPhase 1
Vaccine Therapy, Incomplete Freund's Adjuvant, and GM-CSF in Treating Patients With HIV
United States40 participantsStarted 2006-07
Plain-language summary
RATIONALE: Vaccines made from peptides may help the body build an effective immune response. Incomplete Freund's adjuvant may stimulate the immune system in different ways and may help the vaccine work better. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving vaccine therapy together with incomplete Freund's adjuvant and GM-CSF may be an effective treatment for patients with HIV.
PURPOSE: This clinical trial is studying how well giving vaccine therapy together with incomplete Freund's adjuvant and GM-CSF works in treating patients with HIV.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* HIV-1 infection confirmed by Western blot and enzyme-linked immunosorbent assay
* HLA-A2 positive by polymerase chain reaction-sequence specific primers
* CD4 T-cell count ≥ 300/mm³
* Must be receiving stable regimen of highly active antiretroviral therapy (HAART) that does not include lamivudine or emtricitabine for ≥ 1 month prior to study entry
* Patients on HAART, including lamivudine or emtricitabine, for which there is a medically appropriate regimen that does not include lamivudine or emtricitabine, are eligible if willing to change antiretrovirals
* Viral load \< 50 copies/mL for 1 month prior to study entry
PATIENT CHARACTERISTICS:
* See Disease Characteristics
* ECOG performance status 0-1
* Life expectancy ≥ 6 months
* Hemoglobin ≥ 9 g/dL
* WBC ≥ 1,000/mm³
* Absolute neutrophil count ≥ 750/mm³
* Platelet count ≥ 75,000/mm³
* PT and PTT ≤ 120% of control unless lupus anticoagulant detected
* Bilirubin ≤ 1.5 times upper limit of normal (ULN) (≤ 7.5 mg/dL with direct fraction ≤ 0.7 mg/dL if on protease inhibitor therapy or due to Gilbert's syndrome)
* AST and ALT ≤ 2.5 times ULN
* Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No hepatitis B surface antigen (HBsAg) or a prior history of HBsAg while on lamivudine or emtricitabine
* Prior treatment with tenofovir and currently HBsAg negative allowed
* No evidence of a …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Impact of treatment on immune response, in terms of the difference between cytotoxic T-lymphocyte effector frequency, as measured by enzyme-linked immunospot (ELISPOT) at baseline and at week 20
Trial details
NCT IDNCT00381875
SponsorNational Institutes of Health Clinical Center (CC)