Helping HIV Infected Patients in South Africa Adhere to Drug Regimens

NCT00076804 | Terminated Phase 2 Results DMC

• 1 other identifier: 1R01AI055359-01A1
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 1

Brief Summary

Three or more anti-HIV drugs are taken in combination as part of a treatment regimen. These drug regimens must be closely followed in order to be successful. Having a support person watch a patient take his or her anti-HIV drugs each day may help a patient follow his or her regimen. This study will see if patient-chosen treatment supporters help patients take HIV medicines correctly and improve their health. Study hypothesis: The mean change in CD4 count at 12 and 24 months will be significantly higher in the directly observed therapy-highly active antiretroviral therapy (DOT-HAART) arm as compared to the self-administered arm.

Conditions

HIV Infections

Keywords

Directly Observed Therapy; DOT

Outcome Measures

Primary Outcomes (4)

• Impact of DOT Compared to Self-administered Treatment as Measured by HIV Viral Load at 12 Months of Treatment

  Proportion of Patients with HIV RNA Levels of \<400 at 12 Months - Intention-to-treat

  at 12 and 24 months of treatment

• Impact of DOT Compared to Self-administered Treatment as Measured by HIV Viral Load at 24 Months of Treatment

  Proportion of Patients with HIV RNA Levels of \<400 Copies/mL at 24 Months \[Intention-to-treat (ITT)

  24 months

• Immunological Response: Median CD4 (IQR) Cell Count Increase From Baseline at 12 Months by Study Arm

  12 months

• Immunological Response: Median CD4 (IQR) Cell Count Increase From Baseline at 24 Months by Study Arm

  24 months

Study Arms (2)

1

EXPERIMENTAL

Use of a patient nominated peer supporter who will observe the morning dose of ARVs

Behavioral: Directly Observed Therapy

2

NO INTERVENTION

Self administration of ARVs

Interventions

Directly Observed Therapy BEHAVIORAL

Use of a patient nominated peer supporter who will observe the morning dose of ARVs

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV infected
• Viral load greater than 1000 copies/ml
• CD4 count of 200 cells/mm3 or less, or World Health Organization Stage 4 disease
• Living in the area of the study site
• Had a known address for more than 3 months
• Willing to nominate a treatment supervisor (a close family member, sexual partner, friend, or community volunteer) to observe daily ingestion of tablets
• Willing to disclose HIV status to a treatment supervisor and ready to commit to long-term antiretroviral therapy
• Acceptable methods of contraception

You may not qualify if:

• Pregnant

Sponsors & Collaborators

• Johns Hopkins University: lead
• University of Cape Town: collaborator

Study Sites (1)

University of Cape Town

Cape Town, 7925, South Africa

Location

Related Publications (1)

• Nachega JB, Chaisson RE, Goliath R, Efron A, Chaudhary MA, Ram M, Morroni C, Schoeman H, Knowlton AR, Maartens G. Randomized controlled trial of trained patient-nominated treatment supporters providing partial directly observed antiretroviral therapy. AIDS. 2010 Jun 1;24(9):1273-80. doi: 10.1097/QAD.0b013e328339e20e.

  PMID: 20453627 RESULT

MeSH Terms

Conditions

HIV Infections; Directly Observed Therapy

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Limitations and Caveats

Intervention was stopped at 12 months, transition phase did not ensure that participants developed a set of adherence strategies to replace DOT-ART. Low incidence of AIDS-defining illness and death limit our ability to make final conclusions

Results Point of Contact

• Title: Richard E. Chaisson
• Organization: Johns Hopkins University Center for TB Research

rchaiss@jhmi.edu

4109551755

Study Officials

• Richard E Chaisson, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for TB Research

Study Record Dates

• First Submitted: February 3, 2004
• First Posted: February 6, 2004
• Study Start: February 1, 2005
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: March 27, 2015
• Results First Posted: July 2, 2010

Record last verified: 2015-03

Locations

ZA (1)