HIV Maintenance Therapy With T-20 During HAART Interruption
|First Received Date ICMJE||March 31, 2001|
|Last Updated Date||March 3, 2008|
|Start Date ICMJE||March 2001|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00013884 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||HIV Maintenance Therapy With T-20 During HAART Interruption|
|Official Title ICMJE||A Pilot Study to Evaluate the Ability of Maintenance Therapy With the HIV Fusion Inhibitor T20 to Prevent Rebound of Plasma HIV RNA Following an Interruption of HAART|
This study will evaluate whether a drug called T-20 can slow or prevent a rapid return of HIV in the blood when HAART (highly active antiretroviral therapy) is stopped temporarily. HAART is a multi-dose regimen that is very effective in suppressing HIV and perhaps slowing or halting progression of the viral infection towards AIDS. However, this treatment is not problem-oriented. It cannot completely rid the body of virus, and long-term therapy carries a risk of toxicity (harmful side effects). Moreover, the treatment is difficult to adhere to because of the many pills and capsules that must be taken daily. When patients stop taking HAART, their viral levels climb again. This study will see if T-20 can prolong the time it takes for HIV blood levels to rise in patients who stop HAART temporarily. The results may provide insight into possible new HAART-sparing treatments.
HIV-infected patients 18 years of age and older who have received HAART for at least 1 month may be eligible for this study. Candidates will be screened with a medical history, physical examination, blood and urine tests and possibly a chest X-ray and electrocardiogram (EKG).
Participants will receive either 100 Mg. of T-20 twice a day or 200 Mg. once a day, injected under the skin, and their normal HAART regimen for 3 days. (Patients or a caregiver will be taught how to give the T-20 injections.) On the fourth day, HAART will be stopped and all patients will receive 100 Mg. of T-20 twice a day for 6 weeks. Blood will be drawn weekly from the second to the sixth week after stopping HAART to check viral levels and CD4+ T cell counts. At the end of the 6 weeks, T-20 will be stopped and HAART will be restarted. Patients will then be evaluated once a month until their viral level is less than 50. The final clinic visit will be one month after this time.
In addition to blood draws, patients will undergo leukapheresis before beginning T-20 and possibly again when they restart HAART and at the end of the study. For this procedure, whole blood is collected through a needle placed in an arm vein, similar to donating blood. The blood circulates through a machine that separates it into its components. The white cells are then removed, and the red cells, platelets and plasma are returned to the body, either through the same needle used to draw the blood or through a second needle placed in the other arm. The white cells are used to study T cell function and levels and to detect hidden virus.
Although highly active antiretroviral therapy (HAART) effectively suppresses HIV replication, it is now clear that it cannot completely eradicate HIV from infected individuals. We have also recently begun to appreciate more fully the scope of toxicities and inconveniences associated with HAART medications leading to difficulties with adherence. Thus, long-term use of HAART may be problematic in many HIV-infected individuals. These realizations have led to a search for strategies to shift the focus from eradication to suppression of HIV replication while reducing toxicity and enhancing compliance. One approach to achieve these goals is to attempt to find strategies that allow for prolonged periods off HAART medications. Recently, Trimeris corporation has developed T-20, an inhibitor of HIV fusion to T-cells, a step required to spread virus from cell to cell. This new class of therapy, which has little recognized toxicity, could be used to allow patients to discontinue HAART medications for prolonged periods of time. In this intent to treat pilot study, we propose to evaluate the ability of T-20 to slow or prevent rebound of plasma HIV RNA when HAART medications are interrupted for a single 6 week period. The information obtained through this investigation could provide important insights into novel therapeutic strategies for HIV infection.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment
|Condition ICMJE||HIV Infection|
|Intervention ICMJE||Drug: T-20|
|Study Arm (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||April 2003|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Individuals accepted into the protocol who subsequently violate exclusion criteria 7-9 will be offered further counseling and psychiatric evaluation if indicated. If the situation is not resolved within a reasonable period of time, the PI, in consultation with the care team, may terminate subject participation.
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00013884|
|Other Study ID Numbers ICMJE||010133, 01-I-0133|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Allergy and Infectious Diseases (NIAID)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||April 2003|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP