Enrolling Trials by Subject
We provide access to national and local clinical research trials and studies for persons with HIV-1 in Hawaii, funded by the National Institutes of Health and other agencies. Enrollment is open to the general public. To learn more, please refer to our page, "What is a Clinical Study / Trial?".
Please call us with any questions or if you are interested in joining a trial: 808.737.2751( Oahu and long distance), or, 800.806.8208 (Neighbor Islands, toll free).
Select a category to view trials by subject:
- Treatment-Naive
(have not received any HIV treatment) - Treatment of HIV (Experienced)
- Women's Issues
- HIV-1 Complications
- Vaccine Trials
- Other Trials
- New Trials
Treatment Naive
Treatment Naive is defined as not having received any HIV treatment.
ACTG A5202 - Treatment of HIV
- Purpose: To compare four different antiretroviral combination treatments.
- Description: Randomized to receive Sustiva + Emtriva + Viread OR Sustiva + Ziagen + 3TC OR Reyataz + Norvir + Truvada OR Reyataz + Norvir + Epzicom.
- Criteria: <= 7 days past use of antiretrovirals; HIV RNA > 1000.
- Contact: Nancy at 737-2751
ATP Study
- Purpose: To see if fat cell energy loss causes fat loss.
- Description: Fat biopsy and fasting blood work.
- Criteria: HIV (+) Taking AZT, d4T and/or ddI; no thinning of arms or legs. OR HIV (+) antiretroviral naive. OR HIV (-)
- Contact: Cris at 737-2751
ACTG A5164 - Treatment of HIV
- Purpose: To see whether antiretroviral drugs should be started during an acute infection or deferred until after treatment of the acute infection.
- Description: Randomized to immediate treatment ( within 14 days of starting treatment for infection ) vs. deferred treatment.
- Criteria: Acute infection; no antiretroviral treatment within 8 weeks; no more than 31 days of antiretrovirals within 6 months.
- Contact: Lorna at 737-2751
Acambis Study- Smallpox Vaccination (Open mid Dec.)
- Purpose: To gather information on the side effects of smallpox vaccine for HIV infected people.
- Description: Randomized to MVA3000 smallpox vaccine or placebo
- Criteria: Born after 1971; no history of receiving smallpox vaccine or having past AIDS related illnesses; CD4 200 - 500; HIV RNA< 50,000.
- Contact: Debbie at 737-2751 - Open in mid-Dec.
Treatment Experienced
ACTG A5202 - Treatment of HIV
- Purpose: To compare four different antiretroviral combination treatments.
- Description: Randomized to receive Sustiva + Emtriva + Viread OR Sustiva + Ziagen + 3TC OR Reyataz + Norvir + Truvada OR Reyataz + Norvir + Epzicom.
- Criteria: <= 7 days past use of antiretrovirals; HIV RNA > 1000.
- Contact: Nancy at 737-2751
ACTG A5164 - Treatment of HIV
- Purpose: To see whether antiretroviral drugs should be started during an acute infection or deferred until after treatment of the acute infection.
- Description: Randomized to immediate treatment ( within 14 days of starting treatment for infection ) vs. deferred treatment.
- Criteria: Acute infection; no antiretroviral treatment within 8 weeks; no more than 31 days of antiretrovirals within 6 months.
- Contact: Lorna at 737-2751
ACTG A5175 - Treatment of HIV
- Purpose: To compare 3 types of antiretroviral treatments: Once daily treatment with a protease inhibitor vs. treatment with a once daily non-nucleoside vs. standard twice daily treatment.
- Description: Randomized to receive: AZT / 3TC + Sustiva twice a day, OR ddI + Emtriva + Reyataz once daily, OR Viread + Sustiva + Emtriva once daily.
- Criteria: < = 7 days of past use of antiretrovirals; CD4<300.
- Contact: Lorna at 737-2751
Acambis Study- Smallpox Vaccination (Open mid Dec.)
- Purpose: To gather information on the side effects of smallpox vaccine for HIV infected people.
- Description: Randomized to MVA3000 smallpox vaccine or placebo
- Criteria: Born after 1971; no history of receiving smallpox vaccine or having past AIDS related illnesses; CD4 200 - 500; HIV RNA< 50,000.
- Contact: Debbie at 737-2751 - Open in mid-Dec.
Women's Issues
The studies in this category address women's health issues in particular. All HACRP studies are open to both women and men unless otherwise noted under the study criteria.
ACTG A5188 - Women's PK Study
- Purpose: To measure blood levels of 2 different types of birth control in women taking Kaletra OR not taking a protease inhibitor, or non-nucleosides.
- Description: Several blood draws taken after a birth control patch is used for 3 weeks. Length of study 6 weeks. Compensation available.
- Criteria: Pre-menopausal females; either taking Kaletra OR not on a protease inhibitor, Sustiva, Rescriptor, Viramune; CD4 > 200 ; HIV RNA < 55,000.
- Contact: Cris at 737-2751
HIV-1 Complications
Healthy Heart Study (Now Open)
- Purpose: To learn about the prevalence of cardiac and metabolic side effects of HIV and anti-HIV drugs.
- Description: Observational study. The following will be done: EKG, DEXA scan, blood work, urinalysis, questionnaire.
- Criteria: HIV positive. Study visit scheduled within 30 days of comprehensive blood testing.
- Contact: Jim at 737-2751 - Now Open
ACTG A5184 - Treatment of Hepatitis C (Now Open)
- Purpose: To find out if Hep-C treatment works better if HIV treatment is given first and then Hep-C treatment is given after or if Hep-C treatment given alone without HIV treatment.
- Description: People who have not been treated for Hep-C will be randomized to receive either: ARM A: anti-HIV treatment for up to 30 weeks followed by 48 weeks of anti-HIV treatment plus pegylated interferon plus ribavirin followed by 24 weeks of anti-HIV treatment alone, OR ARM B: pegylated interferon plus ribavirin for up to 48 weeks without anti-HIV treatment
- Criteria: HIV RNA > 1,000; CD4>=300; Infected with Hep-C viral load positive and not treated with IV or subcutaneous interferon for more than 2 weeks in the past; willing to be randomized to postpone anti-HIV treatment as specified by the protocol.
- Contact: Nancy at 737-2751 - Now Open
ACTG A5229 - Treatment of Lipoatrophy (Now Open)
- Purpose: To see whether uridine supplementation has any effect on the fat of the limbs, buttocks and face.
- Description: Randomized to NecleomaxX (uridine supplementation) or placebo for 48 weeks.
- Criteria: Stable antiretroviral drugs that contain AZT or d4T for at least 12 weeks prior to entry; HIV-RNA < 5000; fat loss from at least 2 of the following: face, arms, legs, buttocks.
- Contact: Lorna at 737-2751 - Limited enrollment
HACRP 004 - Treatment for Lipoatrophy
- Purpose: To see if acetyl L-carnitine will reverse fat loss
- Description: All receive active meds; short 24 week study. DEXA, abdominal CT, fat biopsy
- Criteria: Thinning of arms / legs since starting ZDV, ddI or d4T. Currently on and expect to continue antiretrovirals
- Contact: Cris / Dr. Shikuma at 737-2751
ATP Study
- Purpose: To see if fat cell energy loss causes fat loss.
- Description: Fat biopsy and fasting blood work.
- Criteria: HIV (+) Taking AZT, d4T and/or ddI; no thinning of arms or legs. OR HIV (+) antiretroviral naive. OR HIV (-)
- Contact: Cris at 737-2751
Export Control Arm
- Purpose: To study the natural course of fat loss
- Description: 24 weeks observational study. DEXA, abdominal CT, fat biopsy ,fasting bloods.
- Criteria: Thinning of arms / legs since starting AZT, ddI or d4T. Currently on and expect to continue antiretrovirals.
- Contact: Cris / Dr. Shikuma at 737-2751
ACTG A5157 - Treatment of Peripheral Neuropathy
- Purpose: To see if acetyl-L-carnitine (ALC) improves peripheral neuropathy ( PN )
- Description: Open label pilot study of increasing doses of ALC for 24 weeks
- Criteria: Stable antiretroviral drugs that contain either d4T, ddI or ddC >=8 weeks; HIV RNA <= 10,000; must have bilateral pain in feet / legs linked to the use of d4T, ddI or ddC.
- Contact: Debbie at 737-2751
Pfizer Study - Treatment of Peripheral Neuropathy (Open mid Nov.)
- Purpose: To see if pregabalin is effective in reducing peripheral neuropathy pain.
- Description: Randomized to receive one of 3 doses of pregabalin vs. placebo for 12 weeks.
- Criteria: Painful peripheral neuropathy; no diabetes
- Contact: Nancy at 737-2751 - Open mid Nov.
ACTG A5178 - Treatment of Hepatitis C
- Purpose: To look at the role of long - term pegylated interferon + ribaviran in people who are either Hep C treatment naive or who have failed to respond to Hep C treatment in the past.
- Description: People who have not been treated for Hep C will be treated with pegylated interferon + ribaviran x 12 wks, then randomized to either no treatment or continued treatment. People treated in the past will be randomized to no treatment or continued treatment.
- Criteria: HIV RNA < 50,000; CD4 > 200; Hep C viral load positive and not treated for Hep-C OR currently being treated for Hep-C.
- Contact: Nancy at 737-2751
Vaccine Trials
Acambis Study- Smallpox Vaccination (Open mid Dec.)
- Purpose: To gather information on the side effects of smallpox vaccine for HIV infected people.
- Description: Randomized to MVA3000 smallpox vaccine or placebo
- Criteria: Born after 1971; no history of receiving smallpox vaccine or having past AIDS related illnesses; CD4 200 - 500; HIV RNA< 50,000.
- Contact: Debbie at 737-2751 - Open in mid-Dec.
Other Trials
ATP Study
- Purpose: To see if fat cell energy loss causes fat loss.
- Description: Fat biopsy and fasting blood work.
- Criteria: HIV (+) Taking AZT, d4T and/or ddI; no thinning of arms or legs. OR HIV (+) antiretroviral naive. OR HIV (-)
- Contact: Cris at 737-2751
New Trials
Acambis Study- Smallpox Vaccination (Open mid Dec.)
- Purpose: To gather information on the side effects of smallpox vaccine for HIV infected people.
- Description: Randomized to MVA3000 smallpox vaccine or placebo
- Criteria: Born after 1971; no history of receiving smallpox vaccine or having past AIDS related illnesses; CD4 200 - 500; HIV RNA< 50,000.
- Contact: Debbie at 737-2751 - Open in mid-Dec.
Pfizer Study - Treatment of Peripheral Neuropathy (Open mid Nov.)
- Purpose: To see if pregabalin is effective in reducing peripheral neuropathy pain.
- Description: Randomized to receive one of 3 doses of pregabalin vs. placebo for 12 weeks.
- Criteria: Painful peripheral neuropathy; no diabetes
- Contact: Nancy at 737-2751 - Open mid Nov.
Healthy Heart Study (Now Open)
- Purpose: To learn about the prevalence of cardiac and metabolic side effects of HIV and anti-HIV drugs.
- Description: Observational study. The following will be done: EKG, DEXA scan, blood work, urinalysis, questionnaire.
- Criteria: HIV positive. Study visit scheduled within 30 days of comprehensive blood testing.
- Contact: Jim at 737-2751 - Now Open
ACTG A5184 - Treatment of Hepatitis C (Now Open)
- Purpose: To find out if Hep-C treatment works better if HIV treatment is given first and then Hep-C treatment is given after or if Hep-C treatment given alone without HIV treatment.
- Description: People who have not been treated for Hep-C will be randomized to receive either: ARM A: anti-HIV treatment for up to 30 weeks followed by 48 weeks of anti-HIV treatment plus pegylated interferon plus ribavirin followed by 24 weeks of anti-HIV treatment alone, OR ARM B: pegylated interferon plus ribavirin for up to 48 weeks without anti-HIV treatment
- Criteria: HIV RNA > 1,000; CD4>=300; Infected with Hep-C viral load positive and not treated with IV or subcutaneous interferon for more than 2 weeks in the past; willing to be randomized to postpone anti-HIV treatment as specified by the protocol.
- Contact: Nancy at 737-2751 - Now Open
ACTG A5229 - Treatment of Lipoatrophy (Now Open)
- Purpose: To see whether uridine supplementation has any effect on the fat of the limbs, buttocks and face.
- Description: Randomized to NecleomaxX (uridine supplementation) or placebo for 48 weeks.
- Criteria: Stable antiretroviral drugs that contain AZT or d4T for at least 12 weeks prior to entry; HIV-RNA < 5000; fat loss from at least 2 of the following: face, arms, legs, buttocks.
- Contact: Lorna at 737-2751 - Limited enrollment