Study of Anti-HIV Therapy Intensification

• Status: Completed
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to see how the body's immune system changes after replacing and adding new anti-HIV drugs to a patient's current anti-HIV therapy. This study will also see whether adding drugs is safe. Patients who take part in A5136 are also eligible to take part in 2 substudies. The purpose of substudy A5140s is to see how many latently infected cells (cells in which the HIV virus survives) are in the lymph node (small, rounded structures that make disease-fighting cells). Substudy A5155s will be performed to see how many latently infected cells are in the blood before and after replacing and adding anti-HIV drugs.

ACTG A5136 is a follow-up study to ACTG 315 and ACTG 375, which were designed to examine the effects of highly active antiretroviral therapy (HAART) in certain HIV-infected patients. Many HIV-infected patients have undergone long-term anti-HIV therapy and have had the virus suppressed. However, most of these patients still have problems with their immune systems. The reason for these problems is unknown. This study may help researchers understand what causes immune system problems in people who have low levels of HIV in their blood.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Didanosine; Heptavalent Pneumococcal Conjugate Vaccine; Lamivudine; Lamivudine, zidovudine drug combination; Lopinavir; Ritonavir; Stavudine; Tenofovir; Vaccines; Zidovudine

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

• Have completed ACTG 375 within 2 weeks of finishing Week 230.

• Have a viral load less than 400 copies/ml within 90 days prior to study entry.

• Agree not to become pregnant or to impregnate during the study. The female patient/male partner must use acceptable methods of contraception while receiving study drugs and for 1 month after stopping the drugs. Women and men who cannot have children are eligible without requiring the use of contraception, but they must provide acceptable documentation of menopause, sterilization, or lack of sperm cells.

Exclusion Criteria

Patients may not be eligible for this study if they:

• Need to use certain drugs within 30 days of study entry.

• Have taken any immunomodulatory therapies within 30 days prior to study entry unless approved by the protocol chairs.

• Have a history of serious kidney problems.

• Are allergic or sensitive to the study drugs.

• Are pregnant or breast-feeding.

• Have an alcohol or drug dependency that, in the opinion of the investigator, would interfere with the study.