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Home > "H" Clinical Trials Conditions > HIV Expression in Patients with Low Viral Load on Highly Active Antiretroviral Therapy (HAART)  HIV Expression in Patients with Low Viral Load on Highly Active Antiretroviral Therapy (HAART)
HIV Expression in Patients with Low Viral Load on Highly Active Antiretroviral Therapy (HAART)
For Condition: HIV Infections
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: This study will investigate low-level viral loads in HIV-infected patients taking highly active antiretroviral therapy (HAART). Although HAART reduces viral levels and restores immune function to some degree, it does not cure HIV infection. The virus persists even at levels below that which it can be detected. This study will examine where this residual virus comes from in order to better understand the infection and the effectiveness of therapies. In addition, the study will 1) evaluate the ability of a new test to detect the virus at low levels; and 2) determine whether adding the protease inhibitor Kaletra to the HAART treatment regimen for patients with a low viral load will further decrease their viral load. HIV-infected patients 18 years of age and older may be eligible for this study. Patients involved in the viral load test will be recruited from an NIAID HIV study in which they are already participating. Three groups of patients will be enrolled: those with a viral load of less than 50 copies/ml plasma, those with 51-500 copies/ml, and those with 501-5000 copies/ml. Patients involved in the Kaletra trial must have been taking HAART for 6 months or more and have less than 50 viral copies/ml plasma. They will be screened for this study with a history, physical examination, and routine laboratory tests. Participants in the viral load test evaluation will donate 70 ml of blood up to four times. No more than one sample will be collected per day. Participants in the Kaletra trial will have blood samples drawn on two successive days and will then be randomly assigned to one of two treatment groups. One group will begin Kaletra therapy (four capsules two times a day) immediately; the other will undergo observation for 4 weeks before starting Kaletra. Depending on what group they are in, patients will provide blood samples for viral load measurements and clinical samples according to the following schedule: Immediate Kaletra One sample each during weeks 1, 2, and 3, of therapy and two samples during week 4. Delayed Kaletra One sample each during weeks 1, 2, and 3 of observation and two samples during week 4. After starting therapy, one sample will be collected each week during weeks 1, 2, and 3 of therapy and two samples during week 4. In both groups, after the last dose of medicine on day 28, Kaletra therapy will be complete. At the end of therapy, additional blood will be collected for viral sampling as follows: one sample each during weeks 1, 2, and 3, and two samples during week 4 after Kaletra therapy.
Details: This protocol is an exploratory study of HIV expression in patients who are receiving highly active antiviral therapy and who have low viral loads below or near the current limit of detection (50 copies/ml plasma). Recent studies have suggested that patients with suppressed viral loads in this low range have continued HIV expression, but the amount and the origin of this virus remains unknown. The amount of virus expression in plasma is uncertain because the current viral load assays are imprecise in the cutoff range of 50 copies/ml plasma. The origin of the HIV found at low viral loads detected is unknown as well; two possible sources of virus include expression from long lived reservoirs of infected cells, and low level spreading infection to uninfected cells. Determining the origin of HIV expression has clinical importance; currently available HIV drug therapy will have little effect on HIV expression from established reservoirs, but more potent HIV therapy could potentially inhibit a spreading HIV infection. In this study we plan two principal objectives. First, we will investigate the level of HIV expression in plasma samples at low viral loads using a new HIV load assay with enhanced sensitivity and precision in the viral load range of 5 - 100 copies. If data from the survey confirm acceptable performance characteristics for this assay, we will proceed with stage II of the protocol. In stage II we plan to determine, in short-term experiments, whether the incorporation of an additional antiretroviral to suppressive HAART regimens ("intensification HAART") will further suppress plasma virus. If these initial proof-of-concept experiments suggest that HIV may be suppressed by intensification HAART, then we plan to expand the study in a larger controlled trial to determine the degree of suppression possible with intensification therapy. As a secondary objective we will investigate whether it is feasible to study HIV genetic variation in samples from patients with suppressed viral loads using molecular techniques developed to study HIV variation in patients with viral loads greater than 1000 copies/ml plasma (protocol 00-I-0110). We plan to enroll up to 20 new patients in a viral load survey cohort of HIV viral loads, and analyse a series of samples from a randomized completed trial of antiretroviral therapy. Based on information obtained in viral survey (biological variability, fraction of patients with detectable viral loads using the new assay) we return to the board prior to initiating stage II with a determination of sample size for the intensification cohort.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA - Viral Survey Cohort: HIV-1 infection documented by HIV ELISA and WB Age greater than or equal to 18 years old Hemoglobin greater than or equal to 12 mg/dl within the last six weeks On HAART according to current DHHS guidelines. Most recent viral load (within the last 12 weeks): less than 50 by bDNA or RT-PCR (15 patients) 50-500 by bDNA or RT-PCR (3 patients) 501-10,000 by bDNA or RT-PCR (2 patients) EXCLUSION CRITERIA: Any febrile illness (T greater than 38.0 degrees C) in the 3 weeks prior to blood draw Viral Survey Cohort-M98-863 samples Samples from patients enrolled in the completed M98-863 study INCLUSION CRITERIA - Intensification Cohort: HIV-1 infection documented by HIV ELISA and WB Age greater than or equal to 18 years old Hgb greater than or equal to 12 mg/dl CD4 greater than 200 cells/micro litre and CD4% greater than 14% and not requiring prophylaxis for opportunistic infections Therapy with accepted HAART regimen for greater than or equal to 6 months. Viral load less than 50 copies RNA/ml plasma by RT-PCR for at least four months. Viral load greater than 10 copies RNA/ml plasma by ultra low viral load assay or positive in the adapted Amplicor assay Current HAART with: DHHS approved regimen that does not contain a PI. Willingness to take Kaletra in addition to current regimen for 30 days. Willingness to reduce the dose of sildenafil and other co-administered medicines that may be affected by the addition of Kaletra during the course of therapy with Kaletra. Patient must have primary care outside this protocol. EXCLUSION CRITERIA: Requirement for cytotoxic agents including hydroxyurea or vaccinations during the study period Chronic corticosteroid therapy Concurrent Therapy with investigational cytokines including IL-2 or IL-12 during the course of the study. Prior administration of cytokines is not an exclusion criteria; at least 4 months from most recent cycle of IL-2 or IL-12. GCSF and erythropoietin therapy will be permitted History of taking a salvage regimen; i.e., patient has had clinical resistance to antiretrovirals. Changing antiretroviral therapy because of adverse effects is permitted Prior Protease Inhibitor therapy is not permitted unless the previous PI-containing therapy was switched because of patient preference. If pt had a documented history of lipid elevations (fasting triglycerides greater than 750 mg/dl, the patient will not be eligible Any febrile illness (T greater than 38 degrees C) in the 3 weeks prior to enrollment Any vaccination in the 6 weeks prior to enrollment Current pregnancy or lactation, history of pregnancy in the last 4 months Prior history of intolerance to Kaletra Baseline elevated triglycerides greater than 400 mg/dl without lipid lowering agents. Elevated baseline ALT liver function assays greater than 2 fold greater than upper limit of normal History of chronic hepatitis B infection (positive HBV core antigen) or Hepatitis C infection (including positive hepatitis C viral load) History of pancreatitis requiring hospitalization Concomitant use with drugs that are highly dependent on cytochrome P450 for clearance for which, in the opinion of the investigators, may lead to the unexpected changes in their concentrations occurring after the addition of Kaletra. Examples include but are not limited to: wafarin-like anticoagulation, amiodarone, astemizole, cisapride, statin class of drugs, gemfibrizole, cyclosporine, ergonavine, ergotamine, methylergonavine, dihydroergotamine, dofetilide, flecanide, quinidine, fusidic acid, methadone, demerol, midazolam, triazolam, phenytoin, dilantin, pimozide, sirolimus, tacrolimus, propaferone, quinupristin, terfenadine, theophylline, Rifampin, rifapentene, or Rifabutin and illicit substances, including the recreational substance "Ecstasy" methylenedioxymethamphetamine. History of chronic diarrhea or inflammatory bowel disease History of hemophilia Inability to comply with the protocol
Total Enrollment: 40
Location and Contact Information:
National Institute of Allergy and Infectious Diseases (NIAID) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Rosanne Burke 3014357937
Additional Information:
Study ID Numbers: 020232; 02-I-0232
Study Start Date: July 26, 2002
Record last reviewed: April 23, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00043641
Other Hiv Infections Studies:
1. An Evaluation of Pentoxifylline in HIV-Positive Persons With Symptomatic HIV Infection and a Karnofsky Score > 40 Percent and < 100 Percent
2. A Study of Nitazoxanide in Patients with AIDS and Diarrhea Caused by Cryptosporidium
3. Helping HIV Infected Patients in South Africa Adhere to Drug Regimens
4. A Study to Evaluate the Use of Nitazoxanide to Treat Cryptosporidiosis (Diarrhea Caused by the Parasite Cryptosporidium)
5. A Study to Evaluate the Impact of Stopping Treatment for the Prevention of Pneumonia in HIV-Positive Patients Receiving Anti-HIV Drugs Who Have Increased CD4 Cell Counts
Related Studies:
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Other Bethesda Clinical Trials
HIV Expression in Patients with Low Viral Load on Highly Active Antiretroviral Therapy (HAART)
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