Validation of System for Monitoring the Effectiveness of Antiretroviral Therapy in HIV-Infected Patients in Africa

NCT00341393 | Completed

• 2 other identifiers: 99990610106-I-N101
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate a system for predicting the effectiveness of antiretroviral treatment in African HIV clinics where standard testing methods for measuring viral load, such as RNA polymerase chain reaction, are not available or affordable. Without accurate tests to monitor viral load, treatment decisions often are based on insufficient clinical and immunologic information. This study will see if combined analysis of patients' antiretroviral treatment history, adherence to treatment, clinical findings and simple laboratory tests can predict whether their treatment is effectively lowering their viral load. An effective monitoring system such as this could reduce the number of patients kept on ineffective treatments for prolonged periods of time as well as reduce the development of drug resistance. HIV-infected patients 18 years of age and older who are being followed in the Adult Infectious Disease Clinic at Makerere University, Kampala, Uganda, and who have been taking antiretroviral treatment for more than 6 months may be eligible for this study. Participants' medical charts are reviewed and their medical history is taken, including questions about their treatment history, adherence to treatment, and changes in symptoms. A blood sample is drawn to determine viral load, CD4+ and CBC counts, and, if necessary, anti-viral resistance.

Conditions

HIV

Keywords

HIV Infection; AIDS; Viral Load; Retroviral Treatment; Uganda

Eligibility Criteria

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

You may qualify if:

• Willing to provide individual informed consent.
• HIV positive. (HIV status will have been confirmed by recognised external testing centre (eg AIC) or if necessary by the IDI lab using Abbott Determine HIV1-2 plus STAT-PAK (Chembio Diagnostic Systems) rapid tests. Unigold (Trinity Biotech) is available for 'tie-breaker' testing if necessary.
• Currently being followed at the Adult Infectious Disease Clinic.
• Patients who are aged 18 years or more.
• Patients on ART for more than 6 months who are PI naive.

You may not qualify if:

• Inability or unwillingness to provide individual informed consent.
• Patients currently admitted to 'Urgent Care' facility.
• Age less than 18 years.
• Patients enrolled in either 'Clinic' or 'Gates 5B' cohorts.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Infectious Disease Institute of Makerere University

Kampala, Uganda

Location

Related Publications (1)

• Smith CJ, Staszewski S, Sabin CA, Nelson M, Dauer B, Gute P, Johnson MA, Phillips AN, Gazzard B. Use of viral load measured after 4 weeks of highly active antiretroviral therapy to predict virologic outcome at 24 weeks for HIV-1-positive individuals. J Acquir Immune Defic Syndr. 2004 Sep 1;37(1):1155-9. doi: 10.1097/01.qai.0000135958.80919.e4.

  PMID: 15319675 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

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; Slow Virus Diseases

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: February 16, 2006
• Study Completion: November 15, 2007
• Last Updated: July 2, 2017

Record last verified: 2007-11-15

Locations

UG (1)