Adding New Drugs for HIV Infected Patients Failing Current Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00031044|
Recruitment Status : Completed
First Posted : February 22, 2002
Last Update Posted : May 21, 2012
|First Submitted Date ICMJE||February 20, 2002|
|First Posted Date ICMJE||February 22, 2002|
|Last Update Posted Date||May 21, 2012|
|Study Start Date ICMJE||Not Provided|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title ICMJE||Adding New Drugs for HIV Infected Patients Failing Current Therapy|
|Official Title ICMJE||A Randomized Phase I/II Placebo-controlled Study of Amdoxovir (DAPD) Versus Placebo Together With Enfuvirtide (T-20) Plus Optimized Background Therapy for HIV-Infected Subjects Failing Current Therapy|
|Brief Summary||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.|
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, or 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 and is expected to remain stable for at least the first 24 weeks of the study. Only ENF and DAPD will be supplied by this study, but they will not be provided to participants beyond the end of the 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. Participants 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.
In March 2004, participants in this study were unblinded. Participants on DAPD placebo were given the option of discontinuing the placebo and replacing it with an active antiretroviral, if one is available. Participants on active DAPD were given the option of continuing DAPD through Week 48, or discontinuing it and replacing it with another antiretroviral agent. All participants may continue to receive ENF through Week 48.
|Study Type ICMJE||Interventional|
|Study Phase ICMJE||Phase 1
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Condition ICMJE||HIV Infections|
|Study Arms ICMJE||Not Provided|
|Publications *||Gripshover BM, Ribaudo H, Santana J, Gerber JG, Campbell TB, Hogg E, Jarocki B, Hammer SM, Kuritzkes DR; A5118 Team. Amdoxovir versus placebo with enfuvirtide plus optimized background therapy for HIV-1-infected subjects failing current therapy (AACTG A5118). Antivir Ther. 2006;11(5):619-23.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Original Enrollment ICMJE||Same as current|
|Actual Study Completion Date ICMJE||November 2004|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Note: Enrollment into this study was permanently closed on 02/09/04.
|Ages ICMJE||18 Years and older (Adult, Older Adult)|
|Accepts Healthy Volunteers ICMJE||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Puerto Rico, United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00031044|
|Other Study ID Numbers ICMJE||A5118
10936 ( Registry Identifier: DAIDS ES )
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement ICMJE||Not Provided|
|Responsible Party||National Institute of Allergy and Infectious Diseases (NIAID)|
|Study Sponsor ICMJE||National Institute of Allergy and Infectious Diseases (NIAID)|
|Collaborators ICMJE||Not Provided|
|PRS Account||National Institute of Allergy and Infectious Diseases (NIAID)|
|Verification Date||May 2012|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP