CompletedPhase 1

Safety Study of IL-7 in HIV-infected Patients (Inspire)

United States, Canada, France30 participantsStarted 2007-05

Plain-language summary

This study will evaluate the safety of a new experimental drug, IL-7, in people with HIV infection. Animal studies have shown that IL-7 can improve the function and number of infection-fighting cells called T lymphocytes, or T cells. If this study shows that IL-7 is safe, additional studies will be done to see if it can improve the function or numbers of T-cells in HIV-infected persons. HIV-infected persons who have been receiving HAART therapy for at least 12 months before enrolling in the study and have been stable on this treatment for at least 3 months before enrollment may be eligible for this study. Participants have about 10 clinic visits over 3 months. They receive three injections of IL-7, one injection a week for 3 consecutive weeks. The injections are given as a shot under the skin in the arm or leg. On the day of each injection, the participant stays in the clinic for up to 8 hours or longer for observation and collection of blood samples. Three additional visits (one every 3 months) may be scheduled. During the study visits the following may be done: * Medical history, physical examination, blood tests every visit. * Electrocardiogram (EKG) at study days 0 (day of first dose), 1, 7 (day of second dose), 14 (day of third dose) and 21. * Chest x-ray study on day 21. * Blood sample collections at frequent intervals during the first 96 hours after the first dose administration. A catheter (thin plastic tube) may be put into a vein in the arm and left in place to allow several blood samples to be drawn without repeated needle sticks. * Urine tests several times during the study.

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.

Inclusion criteria

. Age greater than or equal to 18 years
. HIV1 infection as documented by any licensed ELISA test kit and confirmed by Western Blot at anytime prior to study entry.
. On HAART for at least 12 months, and stable on treatment for at least 3 months prior to enrollment. HAART is defined as any protease inhibitor (PI or without ritonavir) + 2 nucleoside reverse transcriptase inhibitors (NNRTI) or any non nucleoside reverse transcriptase inhibitors (NNRTI) + 2 NRTIs. NOTE: RTV-boosted PIs will be considered one antiretroviral drug.
. CD4 cell counts greater than or equal to 101 and less than or equal to 400 cells/mm(3) on at least three consecutive measurements (including the screening value) within the previous 6 months prior to enrollment.
. Patient with CD4 cell counts greater than or equal to 101 and less than or equal to 150 cells/mm(3) with a NADIR greater than or equal to 50 if the NADIR was reached less than 24 months prior to enrollment.

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

Safety

Timeframe: 12 weeks

Trial details

NCT IDNCT00477321

SponsorCytheris SA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-10

View on ClinicalTrials.gov More HIV Infections trials

Plain-language summary

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.

Inclusion criteria

. Age greater than or equal to 18 years
. HIV1 infection as documented by any licensed ELISA test kit and confirmed by Western Blot at anytime prior to study entry.
. On HAART for at least 12 months, and stable on treatment for at least 3 months prior to enrollment. HAART is defined as any protease inhibitor (PI or without ritonavir) + 2 nucleoside reverse transcriptase inhibitors (NNRTI) or any non nucleoside reverse transcriptase inhibitors (NNRTI) + 2 NRTIs. NOTE: RTV-boosted PIs will be considered one antiretroviral drug.
. CD4 cell counts greater than or equal to 101 and less than or equal to 400 cells/mm(3) on at least three consecutive measurements (including the screening value) within the previous 6 months prior to enrollment.
. Patient with CD4 cell counts greater than or equal to 101 and less than or equal to 150 cells/mm(3) with a NADIR greater than or equal to 50 if the NADIR was reached less than 24 months prior to enrollment.

Safety Study of IL-7 in HIV-infected Patients (Inspire)

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Safety Study of IL-7 in HIV-infected Patients (Inspire)

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria