Determining the Effects of Observed and Self-Administered Drug Regimens in HIV Infected Adults

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Highly active antiretroviral therapy (HAART) has led to better health and survival rates among people with HIV/AIDS. The purpose of this study was to measure the effect of trained partner supervision when taking medication versus self-administered therapy in HIV infected participants. These participants have had their first virologic failure on a non-nucleoside reverse transcriptase inhibitor (NNRTI)-based HAART regimen and were starting a protease inhibitor (PI)-based HAART regimen at study entry.

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

Details

• Lead Sponsor: AIDS Clinical Trials Group
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Lopinavir; Reverse Transcriptase Inhibitors; Ritonavir; Tenofovir; Zidovudine

Criteria

Inclusion Criteria for Participants:

• HIV infected

• Have experienced or currently experiencing first baseline virologic failure on first NNRTI-based HAART regimen with no history of virologic failure on another regimen OR discontinued first NNRTI-based HAART regimen without the recommendations of clinicians and currently experiencing virologic failure with no history of virologic failure on another regimen. More information on this criterion can be found in the protocol.

• Confirmed virologic failure within 45 days of study entry

• Receiving one of the following NNRTI-based regimens for at least 16 weeks prior to study entry: ZDV+3TC+NVP, ZDV+3TC+EFV, d4T+3TC+NVP or d4T+3TC+EFV

• Able to identify a close friend, relative, or spouse who is willing to serve as a partner

• Intend to stay in current geographical area of residence for the duration of the study

• Agree to use LPV/rtv with MEMS caps and take the tablets out of the container only at dosing

• Willing to use acceptable forms of contraception

• Ability and willingness of participant or legal guardian/representative to give written informed consent.

• Required laboratory values obtained within 45 days prior to study entry.

• Negative serum or urine pregnancy test obtained within 48 hours prior to study entry for women of reproductive potential.

Inclusion Criteria for Partners:

• Not a participant

• Friend, family member, or spouse who knows of the participant's HIV status. Partners do not have to live with participants.

• Willing to attend a 1- to 2-hour taped training session prior to study entry

• Willing to attend study visits with participant at study screening; entry; and Weeks 4, 8, 12, 24, and 52

• Willing to directly observe participant taking at least one dose of LPV/rtv for at least 5 days per week for 24 weeks after stratification of participant

• Willing to act as a positive support for participant

• Willing to notify clinical staff of participant's nonadherence to study assigned regimen

• Willing to notify clinical staff if they are unable to provide mDOT for 2 weeks or more

• Willing to complete medication diary logs

• Willing to complete exit interview

• Agree to have their training session taped (if required).

• For mDOT arm, willing to discuss and decide with participants whether to continue mDOT after Week 24

• At least 18 years old

• Understand that participants have agreed to use LPV/RTV with MEMS caps and take the tablets out of the container only at dosing

• Ability and willingness to give written informed consent.

• No intention to relocate away from current geographical area of residence for the duration of study participation.

Exclusion Criteria for Participants:

• Use of any immunomodulator, HIV vaccine, or other investigational therapy within 45 days of study entry

• Prior treatment with any PI

• Previously diagnosed cancer other than basal cell carcinoma and cutaneous Kaposi's sarcoma

• Use of rifampin or rifabutin within 45 days of study entry or plan use of rifampin or rifabutin

• Requirement for taking any medications that are prohibited by this study. More information on this criterion can be found in the protocol.

• Known allergy to the study medications or their formulations

• Current drug or alcohol use that, in the opinion of the investigator, would interfere with the study

• Acute illness requiring hospitalization within 14 days of study entry

• Active tuberculosis (TB) infection

• Currently incarcerated

• Participation as a partner in this study

• Participation with no access to telephones

• Abnormal laboratory values

• Pregnant, breastfeeding, or intend to become pregnant

Exclusion Criteria for Partners:

• A participant in this study

• Participation as a partner to any other participant

• No access to telephones

• Currently incarcerated