Clinical trials: Acquired Immune Deficiency Syndrome
Human Immunodeficiency Virus
Safety Study of a Dual Anti-HIV Gene Transfer Construct to Treat HIV-1 Infection
This is an early phase research study looking at whether an experimental gene transfer, LVsh5/C46 (also known as Cal-1), is safe and if it can protect the immune system from the effects of HIV without the use of antiretroviral…
- Trial name
- NCT01734850
- Testing
- Busulfan, Cal-1 modified HSPC, Cal-1 modified CD4+ T lymphocytes
- Where
- 2 sites in United States
- Volunteers
- 13 people
- Sponsor
- Calimmune, Inc.
HIV Infections
Proof-of-Concept Clinical Pharmacology Trial for HIV Antigen Presentation Therapeutic Biologic Mix
Conducting an initial small, controlled clinical pharmacology trial to assess for therapeutic biologics activity (proof-of-concept) that suggests the potential for clinical benefit of HIV (+) patients 1.
- Trial name
- HIVGP-BCG (NCT07182838)
- Testing
- HIV Therapeutic Biologic Mix - HIV GP160 plus BCG Vaccine Mix for percutaneous use
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Han Xu, M.D., Ph.D., FAPCR, Medical Director, IRB Chair
Herpes Simplex, HIV Infections
A Comparative Trial of Valacyclovir Hydrochloride ( 256U87 ) and Acyclovir for the Suppression of Anogenital Herpes Infections in HIV-Infected Patients
To determine the safety and efficacy of oral valacyclovir hydrochloride ( 256U87 ) compared to acyclovir in the treatment of recurrent anogenital herpes in HIV-infected patients with CD4 counts = or > 100 cells/mm3.
- Trial name
- NCT00002084
- Testing
- Valacyclovir hydrochloride, Acyclovir
- Where
- 46 sites in United States
- Sponsor
- Glaxo Wellcome
HIV Infections, Acquired Immunodeficiency Syndrome
An Expanded Safety Study of Dapivirine Gel 4759 in Africa
The purpose of this study is to determine whether dapivirine gel 4759 is safe for daily use by healthy women in Kenya, Malawi, Rwanda, South Africa and Tanzania.
- Trial name
- NCT00917891
- Testing
- dapivirine
- Where
- 10 sites in Kenya, Malawi and 3 more
- Volunteers
- 280 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
HIV Infections
A Randomized, Parallel Arm, Comparative, Open Label, Multicenter Study of the Activity and Safety of Two Formulations of Saquinavir in Combination With Other Antiretroviral Drugs
To evaluate the antiviral activity and safety of two formulations of saquinavir in combination with licensed nucleoside antiretroviral drugs.
- Trial name
- NCT00002162
- Testing
- Saquinavir, Lamivudine, Stavudine
- Where
- 27 sites in United States, Canada
- Volunteers
- 140 people
- Sponsor
- Hoffmann-La Roche
HIV Infections
A Double-Blind, Randomized, Comparative Study of Delavirdine Mesylate (U-90152S) in Combination With Didanosine (ddI) Versus ddI Alone in HIV-1 Infected Individuals With CD4 Counts of <= 300/mm3
To evaluate the safety, tolerance, pharmacokinetics, and efficacy of delavirdine mesylate (U-90152S) in combination with didanosine (ddI) versus ddI alone in HIV-positive patients.
- Trial name
- NCT00002123
- Testing
- Delavirdine mesylate, Didanosine
- Where
- 84 sites in United States, Puerto Rico
- Sponsor
- Pharmacia and Upjohn
Lymphatic Disease, HIV Infections
The Safety and Effectiveness of Isoprinosine in Patients With Weakened Immune Systems and Lymph Node Disease
The objective of this Phase III, randomized, double-blind, placebo-controlled study in patients with immunologic deficiency is to determine the effect of Isoprinosine in producing an immuno-restorative response within the study…
- Trial name
- NCT00002296
- Testing
- Inosine pranobex
- Where
- United States
- Sponsor
- Newport Pharmaceuticals International
Acquired Immunodeficiency Syndrome
A Study of Single Dose Nevirapine (NVP) Combined With Combivir® for the Prevention of Mother to Child Transmission (pMTCT) - Treatment Options Preservation Study (TOPS)
To determine whether a regimen of single dose nevirapine combined with either 4 or 7 days of Combivir®, compared to a regimen of single dose nevirapine, for the prevention of mother to child transmission can reduce the rate of…
- Trial name
- NCT00144183
- Testing
- Nevirapine (NVP), Zidovudine (ZCV), 3TC
- Where
- 5 sites in South Africa
- Volunteers
- 407 people
- Sponsor
- Boehringer Ingelheim
Sarcoma, Kaposi, HIV Infections
Randomized, Comparative Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) Versus Bleomycin and Vincristine in the Treatment of AIDS-Related Kaposi's Sarcoma
To determine the efficacy of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the treatment of moderate to severe AIDS-related Kaposi's sarcoma (KS) by comparison with the established therapy BV (bleomycin/vincristine).
- Trial name
- NCT00002105
- Testing
- Doxorubicin hydrochloride (liposomal), Bleomycin sulfate, Vincristine sulfate
- Where
- 4 sites in United States
- Volunteers
- 220 people
- Sponsor
- Sequus Pharmaceuticals
Healthy Participants
A Study to Assess the Bioequivalence of Darunavir When Co-Administrated With Cobicistat Under Fed and Fasted Conditions
The purpose of this study is to evaluate the single-dose pharmacokinetics and bioequivalence of darunavir 800 mg when administered as a fixed dose combination relative to 2 x 400 mg tablets of the commercial tablet formulation…
- Trial name
- NCT01619527
- Testing
- darunavir, cobicistat
- Where
- Belgium
- Volunteers
- 133 people, healthy volunteers welcome
- Sponsor
- Janssen R&D Ireland
Human Immunodeficiency Virus 1
A Safety Study to Evaluate the Antiviral Activity of Darunavir in Combination With Ritonavir in HIV 1 Infected Children
The purpose of this study is to evaluate the pharmacokinetics (what the body does to the medication), safety and antiviral activity to support dose recommendations by body weight of darunavir with low-dose ritonavir (DRV/rtv), in…
- Trial name
- NCT00919854
- Testing
- Darunavir, Ritonavir
- Where
- 8 sites in Argentina, Brazil and 3 more
- Volunteers
- 27 people
- Sponsor
- Tibotec Pharmaceuticals, Ireland
HIV Infections, Gonorrhea
Trial to Evaluate PRO 2000/5 Gels for the Prevention of Vaginally Acquired HIV Infection
The objective of the study is to determine the efficacy and safety of 0.5% and 2% PRO 2000/5 gels compared to placebo in preventing vaginally acquired HIV infection.
- Conditions
- HIV Infections, Gonorrhea, Chlamydial Infections, Genital Herpes
- Trial name
- NCT00262106
- Testing
- PRO 2000/5
- Where
- 6 sites in South Africa, Tanzania and 2 more
- Volunteers
- 9,404 people, healthy volunteers welcome
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Diarrhea, HIV Infections
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Orally Administered SP-303 for the Treatment of Diarrhea in Acquired Immunodeficiency Syndrome (AIDS) Patients
To evaluate the efficacy, safety, and durability of response of SP-303 in decreasing stool weight in AIDS patients with diarrhea over 6 days of treatment.
- Trial name
- NCT00002408
- Testing
- Crofelemer
- Where
- 36 sites in United States, Puerto Rico
- Volunteers
- 300 people
- Sponsor
- Shaman Pharmaceuticals
Candidiasis, Esophageal, HIV Infections
Randomized, Controlled, Double-Blind Study of Itraconazole Oral Solution Versus Fluconazole Tablets for the Treatment of Esophageal Candidiasis.
To evaluate the safety and efficacy of itraconazole oral solution versus fluconazole tablets for the treatment of esophageal candidiasis in immunocompromised patients.
- Trial name
- NCT00002132
- Testing
- Itraconazole, Fluconazole
- Where
- 18 sites in United States
- Sponsor
- Janssen Pharmaceuticals
Healthy Volunteers
Estimate The Effect Of Lersivirine On The Pharmacokinetics Of Abacavir/Lamivudine In Healthy Subjects
This will be an open-label, fixed-sequence, multiple dose crossover study in 14 healthy male and/or female subjects, to estimate the effect of steady state lersivirine on the steady state pharmacokinetics of abacavir/lamivudine.
- Trial name
- NCT01220232
- Testing
- Abacavir/Lamivudine, Lersivirine
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Pfizer
HIV Infections, Acquired Immunodeficiency Syndrome
Vicriviroc in HIV-Treatment Experienced Subjects (Study P04405AM5)
Vicriviroc (vye-kri-VYE-rock) is an investigational drug (not yet approved by Government Regulatory Authorities for commercial use) that belongs to a new class of drugs, called CCR5 receptor blockers.
- Trial name
- NCT00523211
- Testing
- Vicriviroc
- Volunteers
- 506 people
- Sponsor
- Merck Sharp & Dohme LLC
Meningitis, HIV Infections
Open, Non-Comparative Study of Fluconazole in Patients With Coccidioidal Meningitis
The study is intended to examine the efficacy of fluconazole for the treatment of coccidioidal meningitis in patients with new onset of infection, relapse of previous infection, or failed previous therapy.
- Trial name
- NCT00002010
- Testing
- Fluconazole
- Where
- 3 sites in United States
- Sponsor
- Pfizer
Human Immunodeficiency Virus Type 1
A Roll-over Study With Rilpivirine for Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Who Participated in Rilpivirine Pediatric Studies
The purpose of this study is to provide continued access to rilpivirine (RPV) for participants who were treated with RPV in a clinical development pediatric study with rilpivirine and who, at the time of roll-over, experience and…
- Trial name
- NCT02494986
- Testing
- Rilpivirine
- Where
- 8 sites in Portugal, South Africa and 3 more
- Volunteers
- 48 people
- Sponsor
- Janssen Sciences Ireland UC
HIV Infections
Gene Therapy With GX-12 in Combination With HAART for the HIV-1 Infected Patients
The purpose of this study is to assess the safety of GX-12 gene therapy combined with HAART in the HIV-1 infected patients and to investigate the efficacy with the value of plasma viral load and with CD4 counts and HIV-1 specific…
- Trial name
- NCT00517569
- Testing
- GX-12, HAART
- Where
- South Korea
- Volunteers
- 12 people
- Sponsor
- Genexine, Inc.
Human Immunodeficiency Virus (HIV)
A Dose-Escalation Study of MDX-010 Administered Monthly as Immunotherapy in Subjects Infected With Human Immunodeficiency Virus (HIV)
The purpose of this study is to assess the safety and tolerability of 2 or 4 doses of MDX-010 in HIV-infected subjects
- Trial name
- NCT03407105
- Testing
- MDX-010
- Where
- 5 sites in United States
- Volunteers
- 24 people
- Sponsor
- Bristol-Myers Squibb