Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00339456
Status:
COMPLETED
Last Update Posted:
2019-12-17
First Post:
2006-06-19
Brief Title:
Intermittent Versus Continuous HAART Highly Active Antiretroviral Therapy for Treating Chronic HIV Infected Patients in Uganda
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Randomized Controlled Trial of Short Cycle Intermittent Versus Continuous HAART for the Treatment of Chronic HIV Infection in Uganda
Status:
COMPLETED
Status Verified Date:
2014-05-20
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Although highly active antiretroviral therapy HAART has been successful in suppressing plasma HIV RNA levels and providing significant clinical benefit in infected patients it does not eradicate HIV infection It is now clear that virus replication persists despite undetectable plasma viremia in individuals receiving HAART In this regard withdrawing HAART even after prolonged periods of virus suppression leads almost invariably to a rapid rebound of plasma viremia It is also now clear that prolonged continuous HAART carries a risk of significant toxicity and side effects In addition the monetary cost of HAART is prohibitive for many individuals and countries In terms of cost 95 of the HIV-infected individuals in the world are beyond the reach of therapy as a direct consequence of the cost of therapy These observations may argue for a different approach to HAART with the goals of 1 durable suppression of virus replication without an attempt at eradication 2 minimization of toxicity and side effects and improvement in patient life-style and 3 a reduction in cost Preliminary data from a pilot study conducted at the National Institutes of Allergy and Infectious Diseases USA have demonstrated that short cycle structured intermittent therapy 7 days HAART drug followed by 7 days off HAART has maintained suppression of plasma HIV RNA while preserving CD4 T cell counts for up to 80 weeks In addition there was no evidence for increased HIV in reservoir sites nor was there evidence for the development of resistance to antiretroviral drugs Finally there was a decrease in parameters of toxicity This approach may have particular applicability for the treatment of HIV in the Southern Hemisphere Therefore we propose to study the virologic and immunologic effects of short cycle intermittent versus continuous HAART in HIV-infected individuals from the JCRC Kampala Uganda in a randomized controlled intent-to-treat trial We shall evaluate both the 7 days on-HAART7 days off-HAART as well as a 2 days off-HAART5 days on-HAART approach In December 2004 the 77 arm was discontinued
Detailed Description:
Although highly active antiretroviral therapy HAART has been successful in suppressing plasma HIV RNA levels and providing significant clinical benefit in infected patients it does not eradicate HIV infection It is now clear that virus replication persists despite undetectable plasma viremia in individuals receiving HAART In this regard withdrawing HAART even after prolonged periods of virus suppression leads almost invariably to a rapid rebound of plasma viremia It is also now clear that prolonged continuous HAART carries a risk of significant toxicity and side effects In addition the monetary cost of HAART is prohibitive for many individuals and countries In terms of cost 95 percent of the HIV-infected individuals in the world are beyond the reach of therapy as a direct consequence of the cost of therapy These observations may argue for a different approach to HAART with the goals of 1 durable suppression of virus replication without an attempt at eradication 2 minimization of toxicity and side effects and improvement in patient life-style and 3 a reduction in cost Preliminary data from a pilot study conducted at the National Institutes of Allergy and Infectious Diseases USA have demonstrated that short cycle structured intermittent therapy 7 days HAART drug followed by 7 days off HAART has maintained suppression of plasma HIV RNA while preserving CD4 T cell counts for up to 80 weeks In addition there was no evidence for increased HIV in reservoir sites nor was there evidence for the development of resistance to antiretroviral drugs Finally there was a decrease in parameters of toxicity This approach may have particular applicability for the treatment of HIV in the Southern Hemisphere Therefore we propose to study the virologic and immunologic effects of short cycle intermittent versus continuous HAART in HIV-infected individuals from the JCRC Kampala Uganda in a randomized controlled intent-to-treat trial We shall evaluate both the 7 days on-HAART7 days off-HAART as well as a 2 days off-HAART5 days on-HAART approach In December 2004 the 77 arm was discontinued
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-I-N288 | None | None | None |