Intermittent Versus Continuous HAART (Highly Active Antiretroviral Therapy) for Treating Chronic HIV Infected Patients in Uganda

Phase 3

Completed

• Conditions: HIV

• Registration Number: NCT00339456
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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-HAART/7 days off-HAART as well as a 2 days off-HAART/5 days on-HAART approach. In December, 2004, the 7/7 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-HAART/7 days off-HAART as well as a 2 days off-HAART/5 days on-HAART approach. In December, 2004, the 7/7 arm was discontinued.

Study Timeline

• Study Start: 2002-08-21
• Study First Submitted: 2006-06-19
• Study First Submitted QC: 2006-06-19
• Study First Posted: 2006-06-21
• Primary Completion: 2008-02-01
• Study Completion: 2008-02-01
• Status Verified: 2014-05-20
• Last Update Submitted: 2019-12-14
• Last Update Posted: 2019-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 155

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the effects of short cycle intermittent versus continuous HAART on viral load.

Secondary Outcome Measures

Name	Time	Method
To evaluate change in CD4 T-cell counts, change in virus patterns, toxicity and side effects, Quality of Life, and adherence.

Trial Locations

Locations (1)

Joint Clinical Research Center; 🇺🇬 Kampala, Uganda