Advertisement

Topics

Combination Drug Treatment of Pediatric HIV Infection

2014-08-27 03:59:25 | BioPortfolio

Summary

This study will test the safety and effectiveness of hydroxyurea, an anti-cancer drug, given together with the anti-HIV drugs didanosine, stavudine and efavirenz for treating children infected with human immunodeficiency virus (HIV). Some studies have found that hydroxyurea may help certain anti-HIV drugs to work better and that the virus does not become resistant to it, as it does other drugs. This study will also examine how hydroxyurea affects the body's immune system and virus levels.

Patients 3 through 21 years old with HIV infection may be eligible for this 52-week study. They will be screened for eligibility with a thorough physical examination, including chest X-ray, electrocardiogram and echocardiogram, head CT scan, eye examination and blood tests.

All patients in the study will take didanosine twice a day, stavudine twice a day and efavirenz once a day. All patients will also take hydroxyurea twice a day, but some will take a low dose of the drug, while others will take a high dose. Within each of these two groups (high and low dose) some patients will start taking hydroxyurea the same day they begin the anti-HIV drugs; others will not start hydroxyurea until after they have taken the anti-HIV drugs for 5 weeks. Patients will have a physical examination every 3 weeks until week 12, then every 4 weeks until week 24, and then every 8 weeks until the end of the study. Blood tests to measure virus levels will be done every other day for the first 7 days and periodically after that. For the first 8 weeks after starting hydroxyurea, blood tests will be done weekly. An eye examination, chest X-ray, electrocardiogram, and CT scans of the head will be done about every 6 months.

Description

This is a pilot study to determine the safety, toxicity, virologic and immunologic effects of combination therapy with hydroxyurea, a cytostatic chemotherapeutic agent, two nucleoside reverse transcriptase inhibitors and a non-nucleoside reverse transcriptase inhibitor in children with HIV infection. We will enroll HIV-infected children who have detectable viral loads (greater than 10,000 copies/ml). Patients will be stratified upon enrollment by CD4 cell count (less than or greater than 200 CD4 cells/mm(3)). Two dose levels of hydroxyurea will be utilized (7.5 mg/kg/dose twice daily and 12.5 mg/kg/dose twice daily). It is anticipated that 15 patients will be enrolled at the Low Dose Level and 10 patients at the High Dose Level of hydroxyurea within each CD4 cohort, for a total of 50 patients on study. Within each dose level patients will receive the antiretroviral agents didanosine, stavudine and efavirenz beginning on study Day one and will be randomized to receive hydroxyurea either on Day 1 or week 6. The cohorts will be escalated and analyzed separately. The study duration will be 52 weeks. This study will attempt to define an effective and tolerable dose of hydroxyurea.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Conditions

HIV Infection

Intervention

Hydroxyurea

Location

National Cancer Institute (NCI)
Bethesda
Maryland
United States
20892

Status

Completed

Source

National Institutes of Health Clinical Center (CC)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:59:25-0400

Clinical Trials [418 Associated Clinical Trials listed on BioPortfolio]

Safety and Effectiveness of an Anti-HIV Drug Combination With and Without Hydroxyurea in Patients With Early HIV Infection

The purpose of this study is to compare the safety and effectiveness of an anti-HIV drug combination with and without hydroxyurea in patients with early HIV infection. Certain combination...

Effectiveness of Early or Delayed Addition of Hydroxyurea to a Three-Drug Anti-HIV Drug Combination Including Didanosine, in Advanced HIV Patients Who Failed a First or Second Anti-HIV Triple-Drug Therapy

The purpose of this study is to find out whether or not the addition of hydroxyurea to didanosine (ddI) and other anti-HIV medications will result in better control of HIV infection. ...

Combination Therapy of Hydroxyurea With L-Carnitine and Magnesium Chloride in Thalassemia Intermedia

The purpose of this study is determination of the efficacy of combination of hydroxyurea with L-carnitine or magnesium in improving hematologic parameters and cardiac status in patients w...

Effect of Hydroxyurea as Treatment for Primary Desmoid Tumors

The purpose of this study is to examine the response rate of desmoid tumors to hydroxyurea. The investigators hypothesize that hydroxyurea will be a safe, non-toxic alternative to aggressi...

Therapeutic Response Evaluation and Adherence Trial (TREAT)

The primary objectives of this prospective study of hydroxyurea for children with sickle cell anemia are 1) Develop and prospectively evaluate a population pharmacokinetic/pharmacodynamics...

PubMed Articles [6210 Associated PubMed Articles listed on BioPortfolio]

Hydroxyurea embryotoxicity is enhanced in P53-deficient mice.

Hydroxyurea, a ribonucleotide reductase inhibitor, is a potent teratogen in mice, causing severe limb and skeletal defects. The exposure of gestation day nine murine embryos to hydroxyurea elicits an ...

Combined hydroxyurea and ET receptor blockade reduces renal injury in the humanized sickle cell mouse.

The objective of this study is to determine if ambrisentan (ET selective antagonist) and hydroxyurea (HU) treatment has a synergistic effect on renal injury in SCN when compared to HU treatment alone....

Rheological properties of sickle erythrocytes in patients with sickle cell anaemia: the effect of hydroxyurea, fetal hemoglobin and α-thalassaemia.

Determine the effect of foetal haemoglobin (HbF) and α-thalassaemia on red blood cell (RBC) deformability of patients with sickle cell anaemia (SCA) with and without hydroxyurea (HU).

Melanonychia.

A 28-year-old gentleman, a known case of non-transfusion dependent thalassemia (NTDT), presented with blackish discoloration on nails of both hands. He has been taking hydroxyurea for the last six mon...

Optimising genetic transformation of Trypanosoma cruzi using hydroxyurea-induced cell-cycle synchronisation.

The limited flexibility and time-consuming nature of the genetic manipulation procedures applicable to Trypanosoma cruzi continue to restrict the functional dissection of this parasite. We hypothesise...

Medical and Biotech [MESH] Definitions

An antineoplastic agent that inhibits DNA synthesis through the inhibition of ribonucleoside diphosphate reductase.

Infection by a variety of fungi, usually through four possible mechanisms: superficial infection producing conjunctivitis, keratitis, or lacrimal obstruction; extension of infection from neighboring structures - skin, paranasal sinuses, nasopharynx; direct introduction during surgery or accidental penetrating trauma; or via the blood or lymphatic routes in patients with underlying mycoses.

A nontuberculous infection when occurring in humans. It is characterized by pulmonary disease, lymphadenitis in children, and systemic disease in AIDS patients. Mycobacterium avium-intracellulare infection of birds and swine results in tuberculosis.

Infection involving the tissues or organs in the PELVIS.

Infection in humans and animals caused by fungi in the class Zygomycetes. It includes MUCORMYCOSIS and entomophthoramycosis. The latter is a tropical infection of subcutaneous tissue or paranasal sinuses caused by fungi in the order Entomophthorales. Phycomycosis, closely related to zygomycosis, describes infection with members of Phycomycetes, an obsolete classification.

More From BioPortfolio on "Combination Drug Treatment of Pediatric HIV Infection"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Cancer
  Bladder Cancer Brain Cancer Breast Cancer Cancer Cervical Cancer Colorectal Head & Neck Cancers Hodgkin Lymphoma Leukemia Lung Cancer Melanoma Myeloma Ovarian Cancer Pancreatic Cancer ...

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...

AIDS and HIV
AIDS; Acquired Immune Deficiency Syndrome. HIV; Human Immunodeficiency Virus HIV infection causes AIDS. HIV infection also causes the production of anti-HIV antibodies, which forms the test for HIV in patients. People who have the HIV antibodies are ...


Searches Linking to this Trial