Trial · NCT00955968
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence Rates of AIDS - Defining Illness, Serious Non-AIDS Defining, Cardiovascular, Renal, Hepatic Event, or Death | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). | AIDS defining illness, serious non-AIDS defining cardiovascular, renal, or hepatic event, or death refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method. |
| Secondary | Incidence Rate of AIDS - Defining Illness | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). | AIDS defining illness, refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method. |
| Secondary | Incidence Rates of Serious Non- AIDS Defining Cardiovascular, Renal or Hepatic Event | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). | Serious non - AIDS defining cardiovascular, renal, or hepatic event, or death refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method. |
| Secondary | Incidence Rate of Deaths | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). | The incidence rate was obtained by using the Kaplan-Meier method. |
| Secondary | Incidence Rate of HIV/AIDS Related Events | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). | HIV/AIDS related events refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method. |
| Secondary | Incidence Rate of HIV/AIDS Related Events or Death | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). | HIV/AIDS related events or death refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method. |
| Secondary | Incidence Rate of HIV/AIDS Related Events or WHO Clinical Stage 2 or 3 Events | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). | HIV/AIDS related events or WHO Clinical Stage 2 or 3 events refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method. |
| Secondary | Incidence Rate of Grade 2 and Above Toxicity | All laboratory measures were done at entry,4 and 12 weeks after, and then every 3 months until study end. Signs and Symptoms were recorded from study entry to study end. All were followed until July 7, 2015 (an average of 125 weeks of follow-up) | The toxicity events included all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the Division of AIDS (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RSC website (http://rsc.tech-res.com). The incidence rate was obtained by using the Kaplan-Meier method. |
| Secondary | Incidence Rate of Cardiovascular or Other Metabolic Events | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). | This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. Given the results of the primary analyses it was decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH. |
| Secondary | Incidence Rate of Other Targeted Medical Conditions | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). | This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. Given the results of the primary analyses it was decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH. |
| Secondary | Incidence Rate of Any Condition Outlined in Appendix II of Protocol or Death | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). | This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. Given the results of the primary analyses it was decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH. |
| Secondary | Number of Virologic Failure (VF) Participants With HIV Resistance in the Continue HAART Arm | At time of confirmation of VF. HIV-1 RNA testing to identify VF was done at week 4, 12, 24, and every 12 weeks thereafter until study end at an average of 125 weeks. If HIV-1 RNA was above 1000 copies/ml, confirmatory testing was done within 4 weeks. | VF was defined as two successive measurements of HIV-1 RNA above 1000 copies/ml at or after 24 weeks of HAART. HIV drug resistance was defined using the Stanford database (Version 6.2) |
| Secondary | Medication Adherence - Last Time Missed Medications | week 0, 48 and 96 | Medication adherence was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided. |
| Secondary | Medication Adherence - How Closely Followed Schedule | week 0, 48 and 96 | Medication adherence was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided. |
| Secondary | Medication Adherence - How Often Follow Instructions | week 0, 48 and 96 | Medication adherence was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided. |
| Secondary | Medication Adherence - Missed Dose Within Past 4 Days | week 0, 48 and 96 | Medication adherence was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided. |
| Secondary | Quality of Life - General Health Outcome | week 0, 48 and 96 | Quality of Life was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided. |
| Secondary | Quality of Life (QoL) - Health Rating Score | week 0, 48 and 96 | QoL - health rating score was evaluated by a self reported questionnaire. Health rating score of 0 was indicative of death or worst possible health and a score of 100 was being in perfect or best possible health and the mean of score is calculated. Higher scores indicate better Quality of Life (QoL). The range is 0-100 units on a scale |
| Secondary | Changes in Plasma Concentrations of Inflammatory and Thrombogenic Markers | Measured at baseline, after 4 and 12 weeks, and then every 6 months until study termination. All participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). | This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. This outcome required additional funding for laboratory testing which was not available and so this outcome is not reported. |
| Secondary | Cost Effectiveness and Feasibility of Treatment Models | Measured at baseline, after 4 - 12 and 24 weeks, and then every 6 months until study termination. All participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). | This outcome was intended as an exploratory analyses and was not included in the primary analyses. Given the results of the primary analyses and changes in WHO guidelines to recommend lifelong antiretroviral therapy, the protocol team decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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