Status:
COMPLETED
Safety and Pharmacokinetic Study of Fixed Dose Combination of Zidovudine, Lamivudine, and Nevirapine in HIV-Infected Children in Thailand
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
HIV Infections
Eligibility:
All Genders
5-12 years
Phase:
PHASE1
PHASE2
Brief Summary
In 2005, there were 50,620 HIV-infected children living in Thailand. Current anti-HIV regimens, comprised of individual pills for each drug, frequently lead to missed doses. To properly control their ...
Detailed Description
An important factor affecting the therapeutic response to ARVs is adherence. A common reason for poor adherence is high pill burden. A combination fixed dose drug approach appears to be an effective s...
Eligibility Criteria
Inclusion
- Weigh between 6 and 30 kilograms
- HIV infected
- Receiving HAART regimen of NVP and 2 NRTIs. More information on this criterion can be found in the protocol.
- Agree to use two appropriate forms of contraception. More information on this criterion can be found in the protocol.
- Ability to swallow study drugs
- Willing to be hospitalized for 12-hour intensive PK study
- Agree to use two appropriate forms of contraception. More information on this criterion can be found in the protocol.
- Parent or legal guardian able and willing to provide written informed consent
Exclusion
- Certain abnormal laboratory values. More information on this criterion can be found in the protocol.
- Vomiting or diarrhea (greater than Grade 2) within 30 days prior to study entry
- History of immunologic failure. More information on this criterion can be found in the protocol.
- Current treatment for an acute serious bacterial, viral, or opportunistic infection
- History of dose-limiting toxicity requiring treatment discontinuation of any of the study drugs
- Hypersensitivity to study drugs
- Surgical or medical problem affecting gastrointestinal motility or absorption or liver function
- Treatment with experimental drugs within 30 days prior to study entry
- Acute hepatitis
- Chemotherapy for active malignancy
- Any clinically significant diseases or findings during the screening medical history or physical examination that, in the opinion of the investigator, may interfere with the study
- Pregnant
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00672412
Start Date
October 1 2008
End Date
January 1 2010
Last Update
November 9 2021
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Prapokklao Hosp. CRS
Muang District, Changwat Chanthaburi, Thailand, 22000
2
Siriraj Hospital Mahidol University CRS
Bangkok, Ratchathewi, Thailand
3
Chiang Mai University Pediatrics-Obstetrics CRS
Chiang Mai, Thailand, 50200
4
Chonburi Hosp. CRS
Chon Buri, Thailand