A Study to Compare Anti-HIV Drugs Given Twice a Day or Once a Day, With or Without Direct Observation
Public ClinicalTrials.gov record NCT00036452. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Phase II, Open Label Study to Compare Twice Daily and Once Daily Potent Antiretroviral Therapy and to Compare Self-Administered Therapy and Therapy Administered Under Direct Observation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Anti-HIV drug therapy works best when the drugs are taken exactly as prescribed by a doctor. Because anti-HIV therapy often involves multiple drugs, some people have difficulty taking them all correctly. The easier it is to take anti-HIV drugs, the more likely people will take them as prescribed and get the best results. This study will see if people are more successful in taking anti-HIV drugs once a day or twice a day. It also will determine if having a health care professional oversee each weekday dose helps people control their HIV infection. The study will compare taking a three-drug combination twice a day versus taking a three-drug combination just once a day. The study will also compare patients taking the drugs on their own to patients taking the drugs in the presence of a clinical worker. Viral load (amount of HIV in the blood) and drug side effects will be measured.
Study identification
- NCT ID
- NCT00036452
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 402 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 13 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Not listed
- Primary completion
- Not listed
- Completion
- Dec 31, 2005
- Last update posted
- Oct 31, 2021
Ends 2006
United States locations
- U.S. sites
- 27
- U.S. states
- 15
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| USC CRS | Los Angeles | California | 90033-1079 | — |
| Univ. of California Davis Med. Ctr., ACTU | Sacramento | California | — | — |
| Ucsd, Avrc Crs | San Diego | California | 92103 | — |
| University of Colorado Hospital CRS | Aurora | Colorado | 80262 | — |
| Univ. of Miami AIDS CRS | Miami | Florida | 33136 | — |
| Univ. of Hawaii at Manoa, Leahi Hosp. | Honolulu | Hawaii | 96816-2396 | — |
| Indiana Univ. School of Medicine, Infectious Disease Research Clinic | Indianapolis | Indiana | 46202-5250 | — |
| IHV Baltimore Treatment CRS | Baltimore | Maryland | 21201 | — |
| Johns Hopkins Adult AIDS CRS | Baltimore | Maryland | 21287 | — |
| SSTAR, Family Healthcare Ctr. | Fall River | Massachusetts | — | — |
| University of Minnesota, ACTU | Minneapolis | Minnesota | 55455-0392 | — |
| Beth Israel Med. Ctr., ACTU | New York | New York | 10003 | — |
| NY Univ. HIV/AIDS CRS | New York | New York | 10016 | — |
| Univ. of Rochester ACTG CRS | Rochester | New York | 14215 | — |
| AIDS Care CRS | Rochester | New York | 14642-0001 | — |
| McCree McCuller Wellness Ctr. at the Connection, Infectious Disease Unit | Rochester | New York | 14642-0001 | — |
| Unc Aids Crs | Chapel Hill | North Carolina | 27514 | — |
| Regional Center for Infectious Disease, Wendover Medical Center CRS | Greensboro | North Carolina | 27401-1004 | — |
| Wake County Health and Human Services CRS | Raleigh | North Carolina | — | — |
| Univ. of Cincinnati CRS | Cincinnati | Ohio | 45267-0405 | — |
| MetroHealth CRS | Cleveland | Ohio | 44109-1998 | — |
| The Ohio State Univ. AIDS CRS | Columbus | Ohio | — | — |
| Hosp. of the Univ. of Pennsylvania CRS | Philadelphia | Pennsylvania | 19104 | — |
| Pitt CRS | Pittsburgh | Pennsylvania | 15213-2582 | — |
| The Miriam Hosp. ACTG CRS | Providence | Rhode Island | 02906 | — |
| Vanderbilt Therapeutics CRS | Nashville | Tennessee | 37203 | — |
| University of Washington AIDS CRS | Seattle | Washington | 98104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00036452, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 31, 2021 · Synced Sep 2, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00036452 live on ClinicalTrials.gov.