|
Adding New Drugs for HIV Infected Patients Failing Current Therapy Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Adding New Drugs for HIV Infected Patients Failing Current Therapy conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Adding New Drugs for HIV Infected Patients Failing Current Therapy Clinical research trials and Adding New Drugs for HIV Infected Patients Failing Current Therapy healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Adding New Drugs for HIV Infected Patients Failing Current Therapy. Adding New Drugs for HIV Infected Patients Failing Current Therapy Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Adding New Drugs for HIV Infected Patients Failing Current Therapy clinical trial. Test subjects typically receive the most effective healthcare possible for their Adding New Drugs for HIV Infected Patients Failing Current Therapy condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "A" Clinical Trials Conditions > Adding New Drugs for HIV Infected Patients Failing Current Therapy  Adding New Drugs for HIV Infected Patients Failing Current Therapy
Adding New Drugs for HIV Infected Patients Failing Current Therapy
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: Even though powerful anti-HIV drug combinations have been successful in patients with little or no prior anti-HIV therapy, studies have shown that these treatments are less effective in patients who have been treated with nucleoside analogues. This study will test the safety and effectiveness of adding one or two new drugs to a personalized anti-HIV regimen for patients whose previous HIV treatments have failed.
Details: Despite the success of potent combination therapies in patients with limited or no prior antiretroviral therapy, clinical experience demonstrates that these regimens are less likely to achieve durable suppression of HIV-1 replication in patients with extensive prior treatment with nucleoside analogues. The response to treatment of patients who have failed multiple previous regimens has been disappointing. Thus, there is an urgent need for new approaches to the treatment of such patients. Recent studies have shown that it is effective to add investigational drugs to optimized background drug regimens that have been selected based on resistance testing. This study will assess the virologic and immunologic activity of amdoxovir (DAPD) versus placebo in combination with enfuvirtide (T-20, ENF) plus optimized background (OB) antiretroviral therapy for highly treatment-experienced patients. Patients in this study will continue to take their current (failing) antiretroviral regimen until they are registered to the study. Patients will be randomized to receive DAPD or placebo. Patients will receive DAPD or placebo together with ENF plus an OB regimen containing at least three but not more than five antiretroviral agents. The OB regimen will be selected based on the results of a screening HIV-1 drug resistance test. Only ENF and DAPD will be supplied by this study. ENF is injected into the abdomen, deltoid, or the anterior aspect of the thigh. Patients will be taught how to self-administer ENF. Medical staff will observe self-injection of the first dose of ENF and at clinic visits scheduled for Weeks 1, 2, and 4. During Week 4, patients will undergo pharmacokinetic testing. This requires that patients come to the clinic for approximately 12 hours so that blood can be tested at different times after taking the study drugs. After Week 4, there are follow-up visits every 4 weeks until Week 48. Blood work, ophthalmologic exams, and urinalysis are done at all clinic visits, except for Week 1. Patients may continue to receive study treatment beyond Week 24 for up to 48 weeks total, unless they experience a confirmed loss of virologic and immunologic response. Regardless of treatment, all patients are followed for 48 weeks.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - HIV infected - Taken at least two combination anti-HIV treatments containing three or more drugs. In total, the treatments must have lasted at least 24 months and must have included at least two nucleoside reverse transcriptase inhibitors (NRTIs), two protease inhibitors (PIs), and one nonnucleoside reverse transcriptase inhibitor (NNRTI). - Failed two previous combination treatments of three or more drugs - Viral load > 5000 copies/ml on stable (at least 8 weeks) antiretroviral regimen, within 60 days prior to study entry - Willing to stay on the current failing anti-HIV treatment until starting study treatment; may have to remain on failing regimen for an additional 60 days after study screening - Acceptable methods of contraception - Access to optimized background (OB) regimen drugs - Ability to bring OB regimen drugs to screening visit Exclusion Criteria - Prior use of DAPD or ENF - Drug or alcohol use which, in the opinion of the investigator, would interfere with the study - History of any illness that, in the opinion of the investigator, would interfere with study participation - Single kidney or history of more than one episode of kidney stones - Pregnant or breast-feeding - Experimental anti-HIV drug use or use of any agent that acts on the immune system within 60 days prior to entry - Active immunization within 21 days prior to study entry - Acute therapy for a serious infection or illness - Active AIDS-defining opportunistic infection requiring acute treatment - Unexplained fever within 7 days prior to study entry - Cancer that requires chemotherapy - Prior HIV vaccination, except for subunit vaccines that contained only gp120 - Certain mutations in HIV-1 reverse transcriptase - Measurable loss of vision due to lens opacity - Posterior subcapsular cataract - Cortical cataract >= Grade C3 on the Lens Opacities Classification System III (LOCS III) scale - Nuclear opalescence Grade >= NO3 (LOCS III) - Best corrected vision worse than 20/200 - Diabetes mellitus, except for gestational diabetes
Total Enrollment: 50
Location and Contact Information:
Overall Study Official:
ScottHammer, Study Chair, Columbia Presbyterian Medical Center
MetroHealth Med Ctr
Cleveland, Ohio, 441091998
United States
Univ of Puerto Rico
San Juan, , 00936-5067
Puerto Rico
Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Harvard (Massachusetts General Hosp)
Boston, Massachusetts, 02114
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Miami University
Miami, Florida,
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Brigham and Womens Hosp
Boston, Massachusetts, 02118
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: ACTG A5118; AACTG A5118
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00031044
Other Hiv Infections Studies:
1. An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects.
2. A Study of DOX-SL in the Treatment of AIDS-Related Kaposi's Sarcoma
3. Continuing Care and Treatment for Patients with Cancer/AIDS/Skin Disease
4. A Multicenter, Double Blind, Comparative Study of Zidovudine Alone Versus Zidovudine and Acyclovir as Treatment for HIV-Infected Patients With CD4+ Counts Less Than 200 Cells/mm3
5. A Study of Zidovudine Plus Acyclovir in HIV-Infected Patients
Related Studies:
Other HIV Infections Clinical Trials
Other Clinical Trials
Other San Juan Clinical Trials
Adding New Drugs for HIV Infected Patients Failing Current Therapy
|
|
|
|
|
|
|
|
