A Study of HIV-Disease Development in Aging

• Status: Completed
• Trial end date: 2005-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to better understand the relationship between age and HIV disease progression.

This study will explore the possible relationship between age and HIV disease progression. Older age is an important risk factor for faster disease development, but older people may respond better to combination drug therapy. This relationship needs to be understood better.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Emtricitabine; Lopinavir; Ritonavir; Stavudine

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

• Are HIV-positive.

• Are between 13 and 30 years old (need consent of parent or guardian if under 18), or are more than 44 years of age.

• Have a viral load of more than 2000 copies/ml within 60 days of study entry.

• Have a CD4 cell count of less than 600 cells/mm3 within 60 days of study entry. (This reflects a change in the CD4 cell count requirement.)

• Agree to use effective methods of birth control (such as condoms) during and for 12 weeks after the study.

Exclusion Criteria

Patients will not be eligible for this study if they:

• Are pregnant or breast-feeding.

• Have an AIDS-related cancer (except Kaposi's sarcoma) requiring chemotherapy.

• Have hepatitis within 30 days of study entry.

• Have diarrhea (more than 3 liquid stools/day for at least 14 days) within 30 days of study entry.

• Are receiving chemotherapy or radiation treatment.

• Have taken antiretroviral drugs for more than 14 days.

• Have received an HIV vaccine within 30 days of study.

• Have a serious illness or infection within 14 days of the study.

• Have other serious conditions that might interfere with study participation.

• Have taken or plan to take certain other drugs that might affect the study results.