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Interluekin-7 to Treat HIV-Infected People Receiving Antiretroviral Treatment

NCT00105417 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2008-03-04

No results posted yet for this study

Summary

This study will evaluate whether interleukin-7 (IL-7) a drug similar to the natural IL-7 protein produced by the body, is safe to use in people infected with HIV. IL-7 is important in immune system function. In humans, it can extend the life of immune cells called T-cells and increase their function and maturation; in mice, it can speed up immune system recovery following chemotherapy of transplantation; and in monkeys, it can make T-cells increase in numbers. If this study shows that IL-7 is safe, other trials will determine if it can improve the numbers or function of T-cells in HIV-infected people.

Patients 18 years of age and older with HIV infection who have been taking anti-HIV medications for at least 12 months, whose CD4 counts are at least 100 cells/microliter, and whose viral load is no more than 50,000 copies/milliliter may be eligible for this study. Candidates are screened with a physical examination, blood and urine tests, including a blood test for HLA type (a genetic test of markers of the immune system), chest x-ray, electrocardiogram, and ultrasound of the spleen.

Participants undergo the following tests and procedures during 9 visits, as follows:

Pre-entry visit

* Brief physical examination, including examination of lymph nodes and spleen.
* Medical history, including questions about current and past medications.
* Urine pregnancy test for women who are able to become pregnant.
* Blood draw for viral load, immune responses, and other routine safety tests.

Entry visit

* Complete physical examination, including examination of lymph nodes and spleen.
* Routine urine test and urine pregnancy test for women who are able to become pregnant.
* Blood draw for viral load, immune responses, and other routine safety tests.
* IL-7 dosing. Participants are randomly assigned to receive one of five doses of IL-7 (3, 10, 30, 60 or 100 micrograms per kilogram of body weight) or placebo (a salt solution that does not contain IL-7). The dose may be given in one or more injections, with higher doses possibly requiring as many as seven or eight injections. The injections are given subcutaneously (under the skin), usually in the arm or leg. After the injection, patients are monitored closely for 12 hours for skin or allergic reactions. Blood is drawn before the injection and again at 0.5, 1, 1.5, 2, 2.5, 4, 8 and 12 hours after the injection to check blood levels of the study medication.

Follow-up visits

Patients come to the clinic 7 times during follow-up-every day for the first 4 days after the injection, then at 14 days, 4 weeks, and 8 weeks after the injection. At most study visits, patients have the following procedures:

* Brief physical examination, including examination of lymph nodes and spleen.
* Routine urine test and urine pregnancy test for women who are able to become pregnant.
* Blood draw for viral load, immune responses, and other routine safety tests.
* Blood test to measure the amount of study medication in the blood 1, 2, and 3 days after the injection
* Electrocardiogram 1 day after the injection

Conditions

  • HIV Infections
  • HIV

Interventions

DRUG

IL-7

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Purpose
TREATMENT

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Completion
2006-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00105417 on ClinicalTrials.gov